Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-11 @ 7:47 PM
Study NCT ID:
NCT02645318
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2015-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fresh tumor tissue, peripheral blood cells, and plasma samples were collected from each patient.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether ctDNA can detect genomic alterations in peripheral blood that are consistent with those in matched tumor sample', 'timeFrame': '2-3 months'}], 'secondaryOutcomes': [{'measure': 'Concordance of tDNA and plasma ctDNA gene detection in early stage non-small cell lung cancer', 'timeFrame': '2-3months'}, {'measure': 'Correlation of ctDNA concentration with clinical features', 'timeFrame': '2-3months'}, {'measure': 'Comparison of positive predictive value between ctDNA and tumor markers', 'timeFrame': '2-3months'}, {'measure': 'The relationship between ctDNA concentration and disease free survival(DFS）', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Circulating Tumor DNA', 'Lung cancer', 'Targeted sequencing'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.', 'detailedDescription': 'Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC.\n\nWe plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive cases who were suspected of non-small cell lung cancer and underwent curative-intent resection.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is confirmed primary lung cancer by frozen pathologic histology\n* Both the fresh tissue tumor and plasma samples are collected for analysis\n\nExclusion Criteria:\n\n* Patients who received any treatment prior to resection\n* Patients who have a history of malignancy\n* Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma\n* Tumor specimens where insufficient DNA'}, 'identificationModule': {'nctId': 'NCT02645318', 'briefTitle': 'Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Prospective Study of Circulating Tumor DNA Detection by Targeted Sequencing in Surgical Non-Small Cell Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'PTHO1501'}}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Kezhong Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Jun Wang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Feng Lou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'San Valley Biotechnology Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}