Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT03301961
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2017-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiplex Analysis of Circulating Tumor DNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A series of lung cancer patients plasma before and after surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2017-09-30', 'studyFirstSubmitQcDate': '2017-09-30', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer', 'timeFrame': '12 months'}, {'measure': 'The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection', 'timeFrame': '36 months'}, {'measure': 'Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating Tumor DNA', 'Early diagnosis', 'Surveillance', 'Methylation', 'Somatic mutation'], 'conditions': ['Carcinoma', 'Non-small-cell Lung Cancer', 'Lung Neoplasm']}, 'descriptionModule': {'briefSummary': 'Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients', 'detailedDescription': 'Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.\n\nCirculating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patient are found nodules in pulmonary and prepare for surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sign informed consent and consent to participate in this study;\n2. Found small nodules in pulmonary by CT and prepare for surgery;\n\nExclusion Criteria:\n\n1. Malignant tumor history within the past 5 years;\n2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;\n3. No matching tissue or blood samplesUnqualified blood samples\n4. Lesion is pure ground glass opacity.'}, 'identificationModule': {'nctId': 'NCT03301961', 'briefTitle': 'Multiplex Analysis of Circulating Tumor DNA', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'PTHO1701'}}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kezhong Chen, M.D.', 'role': 'CONTACT', 'email': 'mdkzchen@163.com', 'phone': '+8613488752289'}, {'name': 'Jun Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kezhong Chen, MD', 'role': 'CONTACT', 'email': 'mdkzchen@163.com', 'phone': '（+86）13488752289'}, {'name': 'Heng Zhao, MD', 'role': 'CONTACT', 'email': 'zhaohengzhaoheng@126.com', 'phone': '（+86）13683139396'}], 'overallOfficials': [{'name': 'Kezhong Chen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief，Thoracic Surgery Service', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}