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🤖 Automated Parsing Preview 🤖Commit: Original Article | HTML Fixture | Parsed Content Preview Parsed JSON{
"title": "Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer",
"content": "<div><div id=\"tab-body\">\r\n\t\t<div class=\"indent2\">\r\n\t\t\t\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.</div><br>\r\n\r\n \r\n <table class=\"data_table\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n<span class=\"term\">Condition or disease <i class=\"fa fa-info-circle term\"></i></span> </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n <span>Non Small Cell Lung Cancer</span>\r\n </td>\r\n </tr>\r\n </table>\r\n <br>\r\n \r\n \r\n <a id=\"desc\"></a>\r\n\r\n \r\n \r\n \r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment. The total amount of blood withdrawn during the study will be approximately 9 teaspoons. Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred. Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors. As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type. As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study. If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.</div>\r\n<br>\r\n </div>\r\n\r\n\r\n <p>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"studyInfoColTitle\"></th>\r\n <th id=\"studyInfoColData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n<span class=\"term\">Study Type <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>\r\n Observational\r\n \r\n \r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Actual\r\n<span class=\"term\">Enrollment <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>40 participants</td>\r\n </tr>\r\n <tr>\r\n <td>Observational Model:</td>\r\n <td> Cohort</td>\r\n </tr>\r\n <tr>\r\n <td>Time Perspective:</td>\r\n <td> Prospective</td>\r\n </tr>\r\n <tr>\r\n\r\n <td>Official Title:</td>\r\n <td>A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer</td>\r\n </tr>\r\n \r\n <tr>\r\n <td> Actual <span class=\"term\">Study Start Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>May 13, 2016</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Primary Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Study Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n</p></div>\r\n\r\n \r\n \t\t\r\n \r\n <div>\r\n <p>\r\n <table class=\"data_table\" width=\"100%\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n \t\t\t\t<span class=\"term\">Group/Cohort <i class=\"fa fa-info-circle term\"></i></span> \t\t\t </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with surgery\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations, and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with radiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage II treated with surgery & chemotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage III treated with chemoradiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n </table>\r\n </p></div>\r\n <br>\r\n\r\n \r\n \r\n <br>\r\n \r\n <br>\r\n <div class=\"indent3\">\r\n\r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Primary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n \t<li>Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage I or II NSCLC treated with surgery compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment, and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA levels in patients with Stage III NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage III NSCLC treated with chemoradiotherapy compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment , and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA by treatment group [ Time Frame: up to 12 months ]<div class=\"indent2\">To determine the change in ctDNA by treatment group at the following time points: change from Pre-treatment to Post-treatment, and change from Pre-treatment to Follow-up.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Secondary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n <li><span class=\"hit_inf\">Health</span> Related Quality of Life- (HRQL) [ Time Frame: up to 12 months ]<div class=\"indent2\">A two part questionnaire, will be used to assess HRQL: (1) QLQ-C30, a core questionnaire covering general aspects of HRQL, and (2) QLQ-LC13, a lung cancer specific questionnaire. For the QLQ-C30 - All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. For the QLQ-LC13 - All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.</div><br>\r\n </li><li>Number of Packs Smoked Per Day [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of packs of tobacco participants smoked per day will be assessed and recorded</div><br>\r\n </li><li>Number of Years Smoked [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of years participants smoked will be recorded.</div><br>\r\n </li><li>Number of Participants that have a Smoking Status [ Time Frame: up to 12 months ]<div class=\"indent2\">Participants will be asked about their current smoking status (yes/no). These answers will be recorded.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <span class=\"body3\">Biospecimen Retention:   Samples With DNA</span><br>\r\n <div class=\"body3 indent3\">\r\n whole blood and tissue when available\r\n </div>\r\n <br>\r\n \r\n </div>\r\n \r\n\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n<p>\r\n<div class=\"indent2\">\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, <a href=\"https://clinicaltrials.gov/ct2/about-studies/learn\"><u>Learn About Clinical Studies.</u></a>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n\r\n <br>\r\n <div class=\"indent2\">\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"elgType\"></th>\r\n <th id=\"elgData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Ages Eligible for Study:   </td>\r\n <td>18 Years and older   (Adult, Older Adult)</td>\r\n </tr>\r\n <tr>\r\n <td>Sexes Eligible for Study:   </td>\r\n <td>All</td>\r\n </tr>\r\n <tr>\r\n <td>Accepts Healthy Volunteers:   </td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Sampling Method:   </td>\r\n <td>Non-Probability Sample</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n <div class=\"indent2\">Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.</div>\r\n \r\n \r\n <div class=\"indent2\"><p>Inclusion Criteria:</p>\r\n <ul>\r\n <li>Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).</li>\r\n <li>Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.</li>\r\n <li>Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.</li>\r\n <li>Ability to understand and the willingness to sign an IRB-approved informed consent document.</li>\r\n <li>Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.</li>\r\n </ul>\r\n <p>Exclusion Criteria:</p>\r\n <ul>\r\n <li>Females who are pregnant</li>\r\n <li>History of organ transplant.</li>\r\n <li>For stage II and III patients, must be able to receive chemotherapy.</li>\r\n <li>Active cardiovascular issues in the past 6 months.</li>\r\n </ul></div>\r\n \r\n </div>\r\n\r\n </p></div>\r\n\r\n\t\t\t \r\n\r\n<a id=\"contacts\"></a>\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n\r\n\r\n \r\n<div>\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>\r\n To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.\r\n </em>\r\n </p><p>\r\n <em>\r\n Please refer to this study by its ClinicalTrials.gov identifier (NCT number): <strong>NCT03746262</strong>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n <br>\r\n\r\n \r\n \r\n \r\n <a id=\"locn\"></a>\r\n\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"locName\"></th>\r\n <th id=\"locStatus\"></th>\r\n </tr>\r\n </thead>\r\n <tr><td class=\"header3\">United States, North Carolina</td></tr>\r\n <tr>\r\n <td>Wake Forest Baptist Medical Center</td>\r\n <td></td>\r\n </tr>\r\n <tr><td>Winston-Salem, North Carolina, United States, 27157 </td></tr>\r\n </table>\r\n </div>\r\n \r\n \r\n \r\n \r\n <div class=\"indent2\">Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</div>\r\n \r\n <div class=\"indent2\">National Cancer Institute (NCI)</div>\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"role\"></th>\r\n <th id=\"name\"></th>\r\n <th id=\"affiliation\"></th>\r\n <th id=\"address\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Principal Investigator:</td>\r\n <td>Stefan Grant, MD</td>\r\n <td>Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</td>\r\n <td></td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\r\n\r\n\r\n\r\n \r\n\r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n<div class=\"indent2\">\r\n <br>\r\n\r\n\r\n\r\n \r\n \r\n\r\n \r\n \r\n\r\n \r\n \r\n <span class=\"header3\"> Publications:</span>\r\n <div class=\"indent2\">\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n <a href=\"https://clinicaltrials.gov/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.\">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, España P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a>\r\n </div>\r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015.\r\n </div>\r\n <div>\r\n Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041).\r\n </div>\r\n <div>\r\n Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015.\r\n </div>\r\n <div>\r\n Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015.\r\n </div>\r\n <div>\r\n Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015.\r\n </div>\r\n \r\n </div>\r\n <br>\r\n \r\n \r\n \r\n \r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle1\"></th>\r\n <th id=\"colData1\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Responsible Party:</td>\r\n <td>Wake Forest University Health Sciences</td>\r\n </tr>\r\n <tr>\r\n <td>ClinicalTrials.gov Identifier:</td>\r\n <td>\r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/show/NCT03746262\">NCT03746262</a>    \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/archive/NCT03746262\">History of Changes</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Other Study ID Numbers:</td>\r\n <td>\r\n IRB00036520 <br>\r\n <a href=\"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA012197&Fy=all\">\r\n P30CA012197 ( U.S. NIH Grant/Contract )</a><br>\r\n CCCWFU 62A15 ( Other Identifier: NCI )<br>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>First Posted:</td>\r\n <td>November 19, 2018\r\n   \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/keydates/NCT03746262\">Key Record Dates</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Update Posted:</td>\r\n <td>November 21, 2018\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Verified:</td>\r\n <td>November 2018\r\n </td>\r\n </tr>\r\n \r\n \r\n \r\n <tr>\r\n <td>Individual Participant Data (IPD) Sharing Statement:</td>\r\n </tr>\r\n <tr>\r\n <td>Plan to Share IPD:</td>\r\n <td>No</td>\r\n </tr>\r\n \r\n </table>\r\n\r\n <br>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle2\"></th>\r\n <th id=\"colData2\"></th>\r\n </tr>\r\n \r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Drug Product:</td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Device Product:</td>\r\n <td>No</td>\r\n </tr>\r\n </thead>\r\n </table>\r\n \r\n \r\n \r\n \t<br>\r\n\t\t \tKeywords provided by Wake Forest University Health Sciences:\r\n\t\t<div class=\"indent3\">\r\n\t <table class=\"layout_table\" width=\"100%\">\r\n\t <thead>\r\n\t <tr>\r\n\t <th id=\"keywordCol1\"></th>\r\n\t <th id=\"keywordCol2\"></th>\r\n\t </tr>\r\n\t </thead>\r\n\t <tr>\r\n\t <td>\r\n\t \t Non-Metastatic Non-Small Cell Lung Cancer<br>\r\n\t \t Cancer<br>\r\n\t \t Lung Cancer<br>\r\n\t \t circulating tumor-specific DNA (ctDNA)<br>\r\n\t \t non-invasive diagnostic<br>\r\n\t \t </td>\r\n\t \t <td></td>\r\n\t \t </tr>\r\n\t </table>\r\n\t</div>\r\n \r\n \r\n <br>\r\n Additional relevant MeSH terms:\r\n <div class=\"indent3\">\r\n <table class=\"layout_table\" width=\"100%\">\r\n <thead>\r\n <tr>\r\n <th id=\"meshTermCol1\"></th>\r\n <th id=\"meshTermCol2\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n Lung Neoplasms<br>\r\n Carcinoma, Non-Small-Cell Lung<br>\r\n Respiratory Tract Neoplasms<br>\r\n Thoracic Neoplasms<br>\r\n Neoplasms by Site<br>\r\n </td>\r\n <td>\r\n Neoplasms<br>\r\n Lung Diseases<br>\r\n Respiratory Tract Diseases<br>\r\n Carcinoma, Bronchogenic<br>\r\n Bronchial Neoplasms<br>\r\n </td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n \r\n <br>\r\n\r\n\r\n <br>\r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t</div>\r\n\t</div></div>",
"author": "Wake Forest University Health Sciences",
"date_published": "2018-11-21T00:00:00.000Z",
"lead_image_url": null,
"dek": null,
"next_page_url": null,
"url": "https://clinicaltrials.gov/ct2/show/NCT03746262",
"domain": "clinicaltrials.gov",
"word_count": 266,
"direction": "ltr",
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🤖 Automated Parsing Preview 🤖Commit: Original Article | HTML Fixture | Parsed Content Preview Parsed JSON{
"title": "Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer",
"content": "<div><div id=\"tab-body\">\r\n\t\t<div class=\"indent2\">\r\n\t\t\t\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.</div><br>\r\n\r\n \r\n <table class=\"data_table\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n<span class=\"term\">Condition or disease <i class=\"fa fa-info-circle term\"></i></span> </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n <span>Non Small Cell Lung Cancer</span>\r\n </td>\r\n </tr>\r\n </table>\r\n <br>\r\n \r\n \r\n <a id=\"desc\"></a>\r\n\r\n \r\n \r\n \r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment. The total amount of blood withdrawn during the study will be approximately 9 teaspoons. Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred. Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors. As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type. As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study. If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.</div>\r\n<br>\r\n </div>\r\n\r\n\r\n <p>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"studyInfoColTitle\"></th>\r\n <th id=\"studyInfoColData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n<span class=\"term\">Study Type <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>\r\n Observational\r\n \r\n \r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Actual\r\n<span class=\"term\">Enrollment <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>40 participants</td>\r\n </tr>\r\n <tr>\r\n <td>Observational Model:</td>\r\n <td> Cohort</td>\r\n </tr>\r\n <tr>\r\n <td>Time Perspective:</td>\r\n <td> Prospective</td>\r\n </tr>\r\n <tr>\r\n\r\n <td>Official Title:</td>\r\n <td>A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer</td>\r\n </tr>\r\n \r\n <tr>\r\n <td> Actual <span class=\"term\">Study Start Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>May 13, 2016</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Primary Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Study Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n</p></div>\r\n\r\n \r\n \t\t\r\n \r\n <div>\r\n <p>\r\n <table class=\"data_table\" width=\"100%\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n \t\t\t\t<span class=\"term\">Group/Cohort <i class=\"fa fa-info-circle term\"></i></span> \t\t\t </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with surgery\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations, and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with radiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage II treated with surgery & chemotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage III treated with chemoradiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n </table>\r\n </p></div>\r\n <br>\r\n\r\n \r\n \r\n <br>\r\n \r\n <br>\r\n <div class=\"indent3\">\r\n\r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Primary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n \t<li>Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage I or II NSCLC treated with surgery compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment, and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA levels in patients with Stage III NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage III NSCLC treated with chemoradiotherapy compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment , and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA by treatment group [ Time Frame: up to 12 months ]<div class=\"indent2\">To determine the change in ctDNA by treatment group at the following time points: change from Pre-treatment to Post-treatment, and change from Pre-treatment to Follow-up.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Secondary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n <li><span class=\"hit_inf\">Health</span> Related Quality of Life- (HRQL) [ Time Frame: up to 12 months ]<div class=\"indent2\">A two part questionnaire, will be used to assess HRQL: (1) QLQ-C30, a core questionnaire covering general aspects of HRQL, and (2) QLQ-LC13, a lung cancer specific questionnaire. For the QLQ-C30 - All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. For the QLQ-LC13 - All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.</div><br>\r\n </li><li>Number of Packs Smoked Per Day [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of packs of tobacco participants smoked per day will be assessed and recorded</div><br>\r\n </li><li>Number of Years Smoked [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of years participants smoked will be recorded.</div><br>\r\n </li><li>Number of Participants that have a Smoking Status [ Time Frame: up to 12 months ]<div class=\"indent2\">Participants will be asked about their current smoking status (yes/no). These answers will be recorded.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <span class=\"body3\">Biospecimen Retention:   Samples With DNA</span><br>\r\n <div class=\"body3 indent3\">\r\n whole blood and tissue when available\r\n </div>\r\n <br>\r\n \r\n </div>\r\n \r\n\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n<p>\r\n<div class=\"indent2\">\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, <a href=\"https://clinicaltrials.gov/ct2/about-studies/learn\"><u>Learn About Clinical Studies.</u></a>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n\r\n <br>\r\n <div class=\"indent2\">\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"elgType\"></th>\r\n <th id=\"elgData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Ages Eligible for Study:   </td>\r\n <td>18 Years and older   (Adult, Older Adult)</td>\r\n </tr>\r\n <tr>\r\n <td>Sexes Eligible for Study:   </td>\r\n <td>All</td>\r\n </tr>\r\n <tr>\r\n <td>Accepts Healthy Volunteers:   </td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Sampling Method:   </td>\r\n <td>Non-Probability Sample</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n <div class=\"indent2\">Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.</div>\r\n \r\n \r\n <div class=\"indent2\"><p>Inclusion Criteria:</p>\r\n <ul>\r\n <li>Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).</li>\r\n <li>Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.</li>\r\n <li>Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.</li>\r\n <li>Ability to understand and the willingness to sign an IRB-approved informed consent document.</li>\r\n <li>Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.</li>\r\n </ul>\r\n <p>Exclusion Criteria:</p>\r\n <ul>\r\n <li>Females who are pregnant</li>\r\n <li>History of organ transplant.</li>\r\n <li>For stage II and III patients, must be able to receive chemotherapy.</li>\r\n <li>Active cardiovascular issues in the past 6 months.</li>\r\n </ul></div>\r\n \r\n </div>\r\n\r\n </p></div>\r\n\r\n\t\t\t \r\n\r\n<a id=\"contacts\"></a>\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n\r\n\r\n \r\n<div>\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>\r\n To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.\r\n </em>\r\n </p><p>\r\n <em>\r\n Please refer to this study by its ClinicalTrials.gov identifier (NCT number): <strong>NCT03746262</strong>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n <br>\r\n\r\n \r\n \r\n \r\n <a id=\"locn\"></a>\r\n\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"locName\"></th>\r\n <th id=\"locStatus\"></th>\r\n </tr>\r\n </thead>\r\n <tr><td class=\"header3\">United States, North Carolina</td></tr>\r\n <tr>\r\n <td>Wake Forest Baptist Medical Center</td>\r\n <td></td>\r\n </tr>\r\n <tr><td>Winston-Salem, North Carolina, United States, 27157 </td></tr>\r\n </table>\r\n </div>\r\n \r\n \r\n \r\n \r\n <div class=\"indent2\">Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</div>\r\n \r\n <div class=\"indent2\">National Cancer Institute (NCI)</div>\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"role\"></th>\r\n <th id=\"name\"></th>\r\n <th id=\"affiliation\"></th>\r\n <th id=\"address\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Principal Investigator:</td>\r\n <td>Stefan Grant, MD</td>\r\n <td>Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</td>\r\n <td></td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\r\n\r\n\r\n\r\n \r\n\r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n<div class=\"indent2\">\r\n <br>\r\n\r\n\r\n\r\n \r\n \r\n\r\n \r\n \r\n\r\n \r\n \r\n <span class=\"header3\"> Publications:</span>\r\n <div class=\"indent2\">\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n <a href=\"https://clinicaltrials.gov/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.\">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, España P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a>\r\n </div>\r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015.\r\n </div>\r\n <div>\r\n Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041).\r\n </div>\r\n <div>\r\n Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015.\r\n </div>\r\n <div>\r\n Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015.\r\n </div>\r\n <div>\r\n Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015.\r\n </div>\r\n \r\n </div>\r\n <br>\r\n \r\n \r\n \r\n \r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle1\"></th>\r\n <th id=\"colData1\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Responsible Party:</td>\r\n <td>Wake Forest University Health Sciences</td>\r\n </tr>\r\n <tr>\r\n <td>ClinicalTrials.gov Identifier:</td>\r\n <td>\r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/show/NCT03746262\">NCT03746262</a>    \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/archive/NCT03746262\">History of Changes</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Other Study ID Numbers:</td>\r\n <td>\r\n IRB00036520 <br>\r\n <a href=\"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA012197&Fy=all\">\r\n P30CA012197 ( U.S. NIH Grant/Contract )</a><br>\r\n CCCWFU 62A15 ( Other Identifier: NCI )<br>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>First Posted:</td>\r\n <td>November 19, 2018\r\n   \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/keydates/NCT03746262\">Key Record Dates</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Update Posted:</td>\r\n <td>November 21, 2018\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Verified:</td>\r\n <td>November 2018\r\n </td>\r\n </tr>\r\n \r\n \r\n \r\n <tr>\r\n <td>Individual Participant Data (IPD) Sharing Statement:</td>\r\n </tr>\r\n <tr>\r\n <td>Plan to Share IPD:</td>\r\n <td>No</td>\r\n </tr>\r\n \r\n </table>\r\n\r\n <br>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle2\"></th>\r\n <th id=\"colData2\"></th>\r\n </tr>\r\n \r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Drug Product:</td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Device Product:</td>\r\n <td>No</td>\r\n </tr>\r\n </thead>\r\n </table>\r\n \r\n \r\n \r\n \t<br>\r\n\t\t \tKeywords provided by Wake Forest University Health Sciences:\r\n\t\t<div class=\"indent3\">\r\n\t <table class=\"layout_table\" width=\"100%\">\r\n\t <thead>\r\n\t <tr>\r\n\t <th id=\"keywordCol1\"></th>\r\n\t <th id=\"keywordCol2\"></th>\r\n\t </tr>\r\n\t </thead>\r\n\t <tr>\r\n\t <td>\r\n\t \t Non-Metastatic Non-Small Cell Lung Cancer<br>\r\n\t \t Cancer<br>\r\n\t \t Lung Cancer<br>\r\n\t \t circulating tumor-specific DNA (ctDNA)<br>\r\n\t \t non-invasive diagnostic<br>\r\n\t \t </td>\r\n\t \t <td></td>\r\n\t \t </tr>\r\n\t </table>\r\n\t</div>\r\n \r\n \r\n <br>\r\n Additional relevant MeSH terms:\r\n <div class=\"indent3\">\r\n <table class=\"layout_table\" width=\"100%\">\r\n <thead>\r\n <tr>\r\n <th id=\"meshTermCol1\"></th>\r\n <th id=\"meshTermCol2\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n Lung Neoplasms<br>\r\n Carcinoma, Non-Small-Cell Lung<br>\r\n Respiratory Tract Neoplasms<br>\r\n Thoracic Neoplasms<br>\r\n Neoplasms by Site<br>\r\n </td>\r\n <td>\r\n Neoplasms<br>\r\n Lung Diseases<br>\r\n Respiratory Tract Diseases<br>\r\n Carcinoma, Bronchogenic<br>\r\n Bronchial Neoplasms<br>\r\n </td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n \r\n <br>\r\n\r\n\r\n <br>\r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t</div>\r\n\t</div></div>",
"author": "Wake Forest University Health Sciences",
"date_published": "2018-11-21T00:00:00.000Z",
"lead_image_url": null,
"dek": null,
"next_page_url": null,
"url": "https://clinicaltrials.gov/ct2/show/NCT03746262",
"domain": "clinicaltrials.gov",
"word_count": 266,
"direction": "ltr",
"total_pages": 1,
"rendered_pages": 1
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"title": "Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer",
"content": "<div><div id=\"tab-body\">\r\n\t\t<div class=\"indent2\">\r\n\t\t\t\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.</div><br>\r\n\r\n \r\n <table class=\"data_table\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n<span class=\"term\">Condition or disease <i class=\"fa fa-info-circle term\"></i></span> </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n <span>Non Small Cell Lung Cancer</span>\r\n </td>\r\n </tr>\r\n </table>\r\n <br>\r\n \r\n \r\n <a id=\"desc\"></a>\r\n\r\n \r\n \r\n \r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment. The total amount of blood withdrawn during the study will be approximately 9 teaspoons. Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred. Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors. As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type. As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study. If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.</div>\r\n<br>\r\n </div>\r\n\r\n\r\n <p>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"studyInfoColTitle\"></th>\r\n <th id=\"studyInfoColData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n<span class=\"term\">Study Type <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>\r\n Observational\r\n \r\n \r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Actual\r\n<span class=\"term\">Enrollment <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>40 participants</td>\r\n </tr>\r\n <tr>\r\n <td>Observational Model:</td>\r\n <td> Cohort</td>\r\n </tr>\r\n <tr>\r\n <td>Time Perspective:</td>\r\n <td> Prospective</td>\r\n </tr>\r\n <tr>\r\n\r\n <td>Official Title:</td>\r\n <td>A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer</td>\r\n </tr>\r\n \r\n <tr>\r\n <td> Actual <span class=\"term\">Study Start Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>May 13, 2016</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Primary Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Study Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n</p></div>\r\n\r\n \r\n \t\t\r\n \r\n <div>\r\n <p>\r\n <table class=\"data_table\" width=\"100%\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n \t\t\t\t<span class=\"term\">Group/Cohort <i class=\"fa fa-info-circle term\"></i></span> \t\t\t </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with surgery\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations, and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with radiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage II treated with surgery & chemotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage III treated with chemoradiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n </table>\r\n </p></div>\r\n <br>\r\n\r\n \r\n \r\n <br>\r\n \r\n <br>\r\n <div class=\"indent3\">\r\n\r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Primary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n \t<li>Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage I or II NSCLC treated with surgery compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment, and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA levels in patients with Stage III NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage III NSCLC treated with chemoradiotherapy compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment , and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA by treatment group [ Time Frame: up to 12 months ]<div class=\"indent2\">To determine the change in ctDNA by treatment group at the following time points: change from Pre-treatment to Post-treatment, and change from Pre-treatment to Follow-up.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Secondary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n <li><span class=\"hit_inf\">Health</span> Related Quality of Life- (HRQL) [ Time Frame: up to 12 months ]<div class=\"indent2\">A two part questionnaire, will be used to assess HRQL: (1) QLQ-C30, a core questionnaire covering general aspects of HRQL, and (2) QLQ-LC13, a lung cancer specific questionnaire. For the QLQ-C30 - All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. For the QLQ-LC13 - All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.</div><br>\r\n </li><li>Number of Packs Smoked Per Day [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of packs of tobacco participants smoked per day will be assessed and recorded</div><br>\r\n </li><li>Number of Years Smoked [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of years participants smoked will be recorded.</div><br>\r\n </li><li>Number of Participants that have a Smoking Status [ Time Frame: up to 12 months ]<div class=\"indent2\">Participants will be asked about their current smoking status (yes/no). These answers will be recorded.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <span class=\"body3\">Biospecimen Retention:   Samples With DNA</span><br>\r\n <div class=\"body3 indent3\">\r\n whole blood and tissue when available\r\n </div>\r\n <br>\r\n \r\n </div>\r\n \r\n\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n<p>\r\n<div class=\"indent2\">\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, <a href=\"https://clinicaltrials.gov/ct2/about-studies/learn\"><u>Learn About Clinical Studies.</u></a>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n\r\n <br>\r\n <div class=\"indent2\">\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"elgType\"></th>\r\n <th id=\"elgData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Ages Eligible for Study:   </td>\r\n <td>18 Years and older   (Adult, Older Adult)</td>\r\n </tr>\r\n <tr>\r\n <td>Sexes Eligible for Study:   </td>\r\n <td>All</td>\r\n </tr>\r\n <tr>\r\n <td>Accepts Healthy Volunteers:   </td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Sampling Method:   </td>\r\n <td>Non-Probability Sample</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n <div class=\"indent2\">Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.</div>\r\n \r\n \r\n <div class=\"indent2\"><p>Inclusion Criteria:</p>\r\n <ul>\r\n <li>Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).</li>\r\n <li>Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.</li>\r\n <li>Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.</li>\r\n <li>Ability to understand and the willingness to sign an IRB-approved informed consent document.</li>\r\n <li>Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.</li>\r\n </ul>\r\n <p>Exclusion Criteria:</p>\r\n <ul>\r\n <li>Females who are pregnant</li>\r\n <li>History of organ transplant.</li>\r\n <li>For stage II and III patients, must be able to receive chemotherapy.</li>\r\n <li>Active cardiovascular issues in the past 6 months.</li>\r\n </ul></div>\r\n \r\n </div>\r\n\r\n </p></div>\r\n\r\n\t\t\t \r\n\r\n<a id=\"contacts\"></a>\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n\r\n\r\n \r\n<div>\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>\r\n To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.\r\n </em>\r\n </p><p>\r\n <em>\r\n Please refer to this study by its ClinicalTrials.gov identifier (NCT number): <strong>NCT03746262</strong>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n <br>\r\n\r\n \r\n \r\n \r\n <a id=\"locn\"></a>\r\n\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"locName\"></th>\r\n <th id=\"locStatus\"></th>\r\n </tr>\r\n </thead>\r\n <tr><td class=\"header3\">United States, North Carolina</td></tr>\r\n <tr>\r\n <td>Wake Forest Baptist Medical Center</td>\r\n <td></td>\r\n </tr>\r\n <tr><td>Winston-Salem, North Carolina, United States, 27157 </td></tr>\r\n </table>\r\n </div>\r\n \r\n \r\n \r\n \r\n <div class=\"indent2\">Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</div>\r\n \r\n <div class=\"indent2\">National Cancer Institute (NCI)</div>\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"role\"></th>\r\n <th id=\"name\"></th>\r\n <th id=\"affiliation\"></th>\r\n <th id=\"address\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Principal Investigator:</td>\r\n <td>Stefan Grant, MD</td>\r\n <td>Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</td>\r\n <td></td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\r\n\r\n\r\n\r\n \r\n\r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n<div class=\"indent2\">\r\n <br>\r\n\r\n\r\n\r\n \r\n \r\n\r\n \r\n \r\n\r\n \r\n \r\n <span class=\"header3\"> Publications:</span>\r\n <div class=\"indent2\">\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n <a href=\"https://clinicaltrials.gov/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.\">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, España P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a>\r\n </div>\r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015.\r\n </div>\r\n <div>\r\n Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041).\r\n </div>\r\n <div>\r\n Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015.\r\n </div>\r\n <div>\r\n Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015.\r\n </div>\r\n <div>\r\n Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015.\r\n </div>\r\n \r\n </div>\r\n <br>\r\n \r\n \r\n \r\n \r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle1\"></th>\r\n <th id=\"colData1\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Responsible Party:</td>\r\n <td>Wake Forest University Health Sciences</td>\r\n </tr>\r\n <tr>\r\n <td>ClinicalTrials.gov Identifier:</td>\r\n <td>\r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/show/NCT03746262\">NCT03746262</a>    \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/archive/NCT03746262\">History of Changes</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Other Study ID Numbers:</td>\r\n <td>\r\n IRB00036520 <br>\r\n <a href=\"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA012197&Fy=all\">\r\n P30CA012197 ( U.S. NIH Grant/Contract )</a><br>\r\n CCCWFU 62A15 ( Other Identifier: NCI )<br>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>First Posted:</td>\r\n <td>November 19, 2018\r\n   \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/keydates/NCT03746262\">Key Record Dates</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Update Posted:</td>\r\n <td>November 21, 2018\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Verified:</td>\r\n <td>November 2018\r\n </td>\r\n </tr>\r\n \r\n \r\n \r\n <tr>\r\n <td>Individual Participant Data (IPD) Sharing Statement:</td>\r\n </tr>\r\n <tr>\r\n <td>Plan to Share IPD:</td>\r\n <td>No</td>\r\n </tr>\r\n \r\n </table>\r\n\r\n <br>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle2\"></th>\r\n <th id=\"colData2\"></th>\r\n </tr>\r\n \r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Drug Product:</td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Device Product:</td>\r\n <td>No</td>\r\n </tr>\r\n </thead>\r\n </table>\r\n \r\n \r\n \r\n \t<br>\r\n\t\t \tKeywords provided by Wake Forest University Health Sciences:\r\n\t\t<div class=\"indent3\">\r\n\t <table class=\"layout_table\" width=\"100%\">\r\n\t <thead>\r\n\t <tr>\r\n\t <th id=\"keywordCol1\"></th>\r\n\t <th id=\"keywordCol2\"></th>\r\n\t </tr>\r\n\t </thead>\r\n\t <tr>\r\n\t <td>\r\n\t \t Non-Metastatic Non-Small Cell Lung Cancer<br>\r\n\t \t Cancer<br>\r\n\t \t Lung Cancer<br>\r\n\t \t circulating tumor-specific DNA (ctDNA)<br>\r\n\t \t non-invasive diagnostic<br>\r\n\t \t </td>\r\n\t \t <td></td>\r\n\t \t </tr>\r\n\t </table>\r\n\t</div>\r\n \r\n \r\n <br>\r\n Additional relevant MeSH terms:\r\n <div class=\"indent3\">\r\n <table class=\"layout_table\" width=\"100%\">\r\n <thead>\r\n <tr>\r\n <th id=\"meshTermCol1\"></th>\r\n <th id=\"meshTermCol2\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n Lung Neoplasms<br>\r\n Carcinoma, Non-Small-Cell Lung<br>\r\n Respiratory Tract Neoplasms<br>\r\n Thoracic Neoplasms<br>\r\n Neoplasms by Site<br>\r\n </td>\r\n <td>\r\n Neoplasms<br>\r\n Lung Diseases<br>\r\n Respiratory Tract Diseases<br>\r\n Carcinoma, Bronchogenic<br>\r\n Bronchial Neoplasms<br>\r\n </td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n \r\n <br>\r\n\r\n\r\n <br>\r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t</div>\r\n\t</div></div>",
"author": "Wake Forest University Health Sciences",
"date_published": "2018-11-21T00:00:00.000Z",
"lead_image_url": null,
"dek": null,
"next_page_url": null,
"url": "https://clinicaltrials.gov/ct2/show/NCT03746262",
"domain": "clinicaltrials.gov",
"word_count": 266,
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🤖 Automated Parsing Preview 🤖Commit: Original Article | HTML Fixture | Parsed Content Preview Parsed JSON{
"title": "Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer",
"content": "<div><div id=\"tab-body\">\r\n\t\t<div class=\"indent2\">\r\n\t\t\t\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.</div><br>\r\n\r\n \r\n <table class=\"data_table\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n<span class=\"term\">Condition or disease <i class=\"fa fa-info-circle term\"></i></span> </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n <span>Non Small Cell Lung Cancer</span>\r\n </td>\r\n </tr>\r\n </table>\r\n <br>\r\n \r\n \r\n <a id=\"desc\"></a>\r\n\r\n \r\n \r\n \r\n \r\n <div class=\"body3 indent2\">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment. The total amount of blood withdrawn during the study will be approximately 9 teaspoons. Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred. Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors. As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type. As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study. If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.</div>\r\n<br>\r\n </div>\r\n\r\n\r\n <p>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"studyInfoColTitle\"></th>\r\n <th id=\"studyInfoColData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n<span class=\"term\">Study Type <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>\r\n Observational\r\n \r\n \r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Actual\r\n<span class=\"term\">Enrollment <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>40 participants</td>\r\n </tr>\r\n <tr>\r\n <td>Observational Model:</td>\r\n <td> Cohort</td>\r\n </tr>\r\n <tr>\r\n <td>Time Perspective:</td>\r\n <td> Prospective</td>\r\n </tr>\r\n <tr>\r\n\r\n <td>Official Title:</td>\r\n <td>A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer</td>\r\n </tr>\r\n \r\n <tr>\r\n <td> Actual <span class=\"term\">Study Start Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>May 13, 2016</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Primary Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n <tr>\r\n <td> Actual <span class=\"term\">Study Completion Date <i class=\"fa fa-info-circle term\"></i></span> :</td>\r\n <td>August 10, 2018</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n</p></div>\r\n\r\n \r\n \t\t\r\n \r\n <div>\r\n <p>\r\n <table class=\"data_table\" width=\"100%\">\r\n <tr>\r\n <th class=\"header3 pale_banner_color\">\r\n \t\t\t\t<span class=\"term\">Group/Cohort <i class=\"fa fa-info-circle term\"></i></span> \t\t\t </th>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with surgery\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations, and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage I treated with radiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage II treated with surgery & chemotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td class=\"body3\">\r\n Patients - Stage III treated with chemoradiotherapy\r\n<div class=\"indent2\">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>\r\n </td>\r\n </tr>\r\n </table>\r\n </p></div>\r\n <br>\r\n\r\n \r\n \r\n <br>\r\n \r\n <br>\r\n <div class=\"indent3\">\r\n\r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Primary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n \t<li>Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage I or II NSCLC treated with surgery compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment, and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA levels in patients with Stage III NSCLC [ Time Frame: up to 12 months ]<div class=\"indent2\">ctDNA levels in patients with Stage III NSCLC treated with chemoradiotherapy compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment , and Follow-up.</div><br>\r\n \t</li><li>Change in ctDNA by treatment group [ Time Frame: up to 12 months ]<div class=\"indent2\">To determine the change in ctDNA by treatment group at the following time points: change from Pre-treatment to Post-treatment, and change from Pre-treatment to Follow-up.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <div class=\"body3\">\r\n<span class=\"term\">Secondary Outcome Measures <i class=\"fa fa-info-circle term\"></i></span> :\r\n <ol>\r\n <li><span class=\"hit_inf\">Health</span> Related Quality of Life- (HRQL) [ Time Frame: up to 12 months ]<div class=\"indent2\">A two part questionnaire, will be used to assess HRQL: (1) QLQ-C30, a core questionnaire covering general aspects of HRQL, and (2) QLQ-LC13, a lung cancer specific questionnaire. For the QLQ-C30 - All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. For the QLQ-LC13 - All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.</div><br>\r\n </li><li>Number of Packs Smoked Per Day [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of packs of tobacco participants smoked per day will be assessed and recorded</div><br>\r\n </li><li>Number of Years Smoked [ Time Frame: up to 12 months ]<div class=\"indent2\">The number of years participants smoked will be recorded.</div><br>\r\n </li><li>Number of Participants that have a Smoking Status [ Time Frame: up to 12 months ]<div class=\"indent2\">Participants will be asked about their current smoking status (yes/no). These answers will be recorded.</div><br>\r\n </li></ol>\r\n </div>\r\n <br>\r\n \r\n \r\n <span class=\"body3\">Biospecimen Retention:   Samples With DNA</span><br>\r\n <div class=\"body3 indent3\">\r\n whole blood and tissue when available\r\n </div>\r\n <br>\r\n \r\n </div>\r\n \r\n\t\t\t \r\n\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n<p>\r\n<div class=\"indent2\">\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, <a href=\"https://clinicaltrials.gov/ct2/about-studies/learn\"><u>Learn About Clinical Studies.</u></a>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n\r\n <br>\r\n <div class=\"indent2\">\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"elgType\"></th>\r\n <th id=\"elgData\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Ages Eligible for Study:   </td>\r\n <td>18 Years and older   (Adult, Older Adult)</td>\r\n </tr>\r\n <tr>\r\n <td>Sexes Eligible for Study:   </td>\r\n <td>All</td>\r\n </tr>\r\n <tr>\r\n <td>Accepts Healthy Volunteers:   </td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Sampling Method:   </td>\r\n <td>Non-Probability Sample</td>\r\n </tr>\r\n </table>\r\n\r\n \r\n <div class=\"indent2\">Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.</div>\r\n \r\n \r\n <div class=\"indent2\"><p>Inclusion Criteria:</p>\r\n <ul>\r\n <li>Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).</li>\r\n <li>Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.</li>\r\n <li>Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.</li>\r\n <li>Ability to understand and the willingness to sign an IRB-approved informed consent document.</li>\r\n <li>Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.</li>\r\n </ul>\r\n <p>Exclusion Criteria:</p>\r\n <ul>\r\n <li>Females who are pregnant</li>\r\n <li>History of organ transplant.</li>\r\n <li>For stage II and III patients, must be able to receive chemotherapy.</li>\r\n <li>Active cardiovascular issues in the past 6 months.</li>\r\n </ul></div>\r\n \r\n </div>\r\n\r\n </p></div>\r\n\r\n\t\t\t \r\n\r\n<a id=\"contacts\"></a>\r\n<div class=\"indent1\">\r\n\r\n<br>\r\n\r\n\r\n<div class=\"indent2\">\r\n\r\n\r\n\r\n \r\n<div>\r\n <div class=\"usa-alert usa-alert-warning\">\r\n <strong>Information from the National Library of Medicine</strong>\r\n \r\n <p>\r\n <em>\r\n To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.\r\n </em>\r\n </p><p>\r\n <em>\r\n Please refer to this study by its ClinicalTrials.gov identifier (NCT number): <strong>NCT03746262</strong>\r\n </em>\r\n </p></div>\r\n</div>\r\n\r\n <br>\r\n\r\n \r\n \r\n \r\n <a id=\"locn\"></a>\r\n\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"locName\"></th>\r\n <th id=\"locStatus\"></th>\r\n </tr>\r\n </thead>\r\n <tr><td class=\"header3\">United States, North Carolina</td></tr>\r\n <tr>\r\n <td>Wake Forest Baptist Medical Center</td>\r\n <td></td>\r\n </tr>\r\n <tr><td>Winston-Salem, North Carolina, United States, 27157 </td></tr>\r\n </table>\r\n </div>\r\n \r\n \r\n \r\n \r\n <div class=\"indent2\">Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</div>\r\n \r\n <div class=\"indent2\">National Cancer Institute (NCI)</div>\r\n \r\n \r\n \r\n <div class=\"table_cover\">\r\n <table class=\"layout_table indent2\">\r\n <thead>\r\n <tr>\r\n <th id=\"role\"></th>\r\n <th id=\"name\"></th>\r\n <th id=\"affiliation\"></th>\r\n <th id=\"address\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Principal Investigator:</td>\r\n <td>Stefan Grant, MD</td>\r\n <td>Wake Forest University <span class=\"hit_inf\">Health</span> Sciences</td>\r\n <td></td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\r\n\r\n\r\n\r\n \r\n\r\n\r\n<div class=\"indent1\">\r\n\r\n\r\n<div class=\"indent2\">\r\n <br>\r\n\r\n\r\n\r\n \r\n \r\n\r\n \r\n \r\n\r\n \r\n \r\n <span class=\"header3\"> Publications:</span>\r\n <div class=\"indent2\">\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n <a href=\"https://clinicaltrials.gov/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.\">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, España P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a>\r\n </div>\r\n \r\n \r\n \r\n \r\n \r\n \r\n <div>\r\n Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015.\r\n </div>\r\n <div>\r\n Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041).\r\n </div>\r\n <div>\r\n Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015.\r\n </div>\r\n <div>\r\n Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015.\r\n </div>\r\n <div>\r\n Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015.\r\n </div>\r\n \r\n </div>\r\n <br>\r\n \r\n \r\n \r\n \r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle1\"></th>\r\n <th id=\"colData1\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>Responsible Party:</td>\r\n <td>Wake Forest University Health Sciences</td>\r\n </tr>\r\n <tr>\r\n <td>ClinicalTrials.gov Identifier:</td>\r\n <td>\r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/show/NCT03746262\">NCT03746262</a>    \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/archive/NCT03746262\">History of Changes</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Other Study ID Numbers:</td>\r\n <td>\r\n IRB00036520 <br>\r\n <a href=\"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA012197&Fy=all\">\r\n P30CA012197 ( U.S. NIH Grant/Contract )</a><br>\r\n CCCWFU 62A15 ( Other Identifier: NCI )<br>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>First Posted:</td>\r\n <td>November 19, 2018\r\n   \r\n <a class=\"study-link\" href=\"https://clinicaltrials.gov/ct2/keydates/NCT03746262\">Key Record Dates</a>\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Update Posted:</td>\r\n <td>November 21, 2018\r\n </td>\r\n </tr>\r\n <tr>\r\n <td>Last Verified:</td>\r\n <td>November 2018\r\n </td>\r\n </tr>\r\n \r\n \r\n \r\n <tr>\r\n <td>Individual Participant Data (IPD) Sharing Statement:</td>\r\n </tr>\r\n <tr>\r\n <td>Plan to Share IPD:</td>\r\n <td>No</td>\r\n </tr>\r\n \r\n </table>\r\n\r\n <br>\r\n <table class=\"layout_table\">\r\n <thead>\r\n <tr>\r\n <th id=\"colTitle2\"></th>\r\n <th id=\"colData2\"></th>\r\n </tr>\r\n \r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Drug Product:</td>\r\n <td>No</td>\r\n </tr>\r\n <tr>\r\n <td>Studies a U.S. FDA-regulated Device Product:</td>\r\n <td>No</td>\r\n </tr>\r\n </thead>\r\n </table>\r\n \r\n \r\n \r\n \t<br>\r\n\t\t \tKeywords provided by Wake Forest University Health Sciences:\r\n\t\t<div class=\"indent3\">\r\n\t <table class=\"layout_table\" width=\"100%\">\r\n\t <thead>\r\n\t <tr>\r\n\t <th id=\"keywordCol1\"></th>\r\n\t <th id=\"keywordCol2\"></th>\r\n\t </tr>\r\n\t </thead>\r\n\t <tr>\r\n\t <td>\r\n\t \t Non-Metastatic Non-Small Cell Lung Cancer<br>\r\n\t \t Cancer<br>\r\n\t \t Lung Cancer<br>\r\n\t \t circulating tumor-specific DNA (ctDNA)<br>\r\n\t \t non-invasive diagnostic<br>\r\n\t \t </td>\r\n\t \t <td></td>\r\n\t \t </tr>\r\n\t </table>\r\n\t</div>\r\n \r\n \r\n <br>\r\n Additional relevant MeSH terms:\r\n <div class=\"indent3\">\r\n <table class=\"layout_table\" width=\"100%\">\r\n <thead>\r\n <tr>\r\n <th id=\"meshTermCol1\"></th>\r\n <th id=\"meshTermCol2\"></th>\r\n </tr>\r\n </thead>\r\n <tr>\r\n <td>\r\n Lung Neoplasms<br>\r\n Carcinoma, Non-Small-Cell Lung<br>\r\n Respiratory Tract Neoplasms<br>\r\n Thoracic Neoplasms<br>\r\n Neoplasms by Site<br>\r\n </td>\r\n <td>\r\n Neoplasms<br>\r\n Lung Diseases<br>\r\n Respiratory Tract Diseases<br>\r\n Carcinoma, Bronchogenic<br>\r\n Bronchial Neoplasms<br>\r\n </td>\r\n </tr>\r\n </table>\r\n </div>\r\n \r\n \r\n <br>\r\n\r\n\r\n <br>\r\n\r\n</div>\r\n</div>\r\n\t\t\t\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t\t\r\n\t\t</div>\r\n\t</div></div>",
"author": "Wake Forest University Health Sciences",
"date_published": "2018-11-21T00:00:00.000Z",
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🤖 Automated Parsing Preview 🤖Commit: Original Article | HTML Fixture | Parsed Content Preview Parsed JSON{
"title": "Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer - Full Text View - ClinicalTrials.gov",
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"content": "<div><div class=\"tr-indent2\"> <div> <a href=\"/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.\">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, España P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a> </div> <p> Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015. </p> <p> Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041). </p> <p> Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015. </p> <p> Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015. </p> <p> Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015. </p> </div><div class=\"tr-indent3\"> <table class=\"tr-layout_table\"> <thead> <tr> <th id=\"keywordCol1\"></th> <th id=\"keywordCol2\"></th> </tr> </thead> <tr> <td> Non-Metastatic Non-Small Cell Lung Cancer Cancer Lung Cancer circulating tumor-specific DNA (ctDNA) non-invasive diagnostic</td> <td></td> </tr> </table> </div><div class=\"tr-indent3\"> <table class=\"tr-layout_table\"> <caption>Layout table for MeSH terms</caption> <thead> <tr> <th id=\"meshTermCol1\"></th> <th id=\"meshTermCol2\"></th> </tr> </thead> <tr> <td> Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site</td> <td> Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms</td> </tr> </table> </div></div>",
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🤖 Automated Parsing Preview 🤖Commit: Original Article | HTML Fixture | Parsed Content Preview Parsed JSON{
"title": "Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer - Full Text View - ClinicalTrials.gov",
"author": null,
"date_published": null,
"dek": null,
"lead_image_url": "https://clinicaltrials.gov/ct2/html/images/ct.gov-nlm-nih-logo.png",
"content": "<div><div class=\"tr-indent2\"> <div> <a href=\"/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.\">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, España P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a> </div> <p> Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015. </p> <p> Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041). </p> <p> Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015. </p> <p> Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015. </p> <p> Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015. </p> </div><div class=\"tr-indent3\"> <table class=\"tr-layout_table\"> <thead> <tr> <th id=\"keywordCol1\"></th> <th id=\"keywordCol2\"></th> </tr> </thead> <tr> <td> Non-Metastatic Non-Small Cell Lung Cancer Cancer Lung Cancer circulating tumor-specific DNA (ctDNA) non-invasive diagnostic</td> <td></td> </tr> </table> </div><div class=\"tr-indent3\"> <table class=\"tr-layout_table\"> <caption>Layout table for MeSH terms</caption> <thead> <tr> <th id=\"meshTermCol1\"></th> <th id=\"meshTermCol2\"></th> </tr> </thead> <tr> <td> Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site</td> <td> Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms</td> </tr> </table> </div></div>",
"next_page_url": null,
"url": "http://example.com/ct2/show/NCT03746262",
"domain": "example.com",
"word_count": 271,
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}
✅ All tests passed |
toufic-m
approved these changes
May 27, 2019
saar
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Jun 2, 2019
* Add prototype of custom extractor for clinicaltrials.gov * Add .DS_Store to gitignore * Make tests for title, author and date_published selectors pass * Make content selector test pass * Fix date_published test * Rebuild * Remove .DS-Store from gitignore * Improve extractor and text/fixture of clinicaltrials.gov
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