Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 6:35 PM
Study NCT ID:
NCT04287335
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4758}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, plus a hemoglobin immunoassay. A logistic-regression algorithm incorporating all the above parameters was deployed to compute a single composite score, with values of 165 or more considered to be positive. The tests were processed independently of colonoscopy procedure.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The ColoClear and FIT test were performed on the same stool sample.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Colorectal Cancer', 'Colorectal Neoplasms', 'Adenomatous Polyps', 'Adenoma', 'Advanced adenoma', 'Gastrointestinal Diseases', 'Colonic Diseases', 'Neoplasms', 'Digestive System Diseases', 'Intestinal Neoplasms', 'Gastrointestinal Neoplasms', 'Digestive System Neoplasms', 'Neoplasms by Site', 'Intestinal Diseases', 'Rectal Diseases', 'Glandular and Epithelial', 'Neoplasms by Histologic Type'], 'conditions': ['Colorectal Cancer', 'Adenomatous Polyps', 'Adenoma', 'Advanced Adenoma']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.', 'detailedDescription': 'The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with high risk of developing CRC and patients with confirmed CRC', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing to provide written consent\n* Able to provide stool sample\n\nFor high risk CRC screening group:\n\n* Scheduled for colonoscopy voluntarily or by physician prescription\n* CRC high risk profile as defined below:\n* History of FIT positivity\n* Family history of CRC\n* Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress\n\nFor CRC group:\n\n* Confirmed CRC patients\n* No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures\n\nExclusion Criteria:\n\n* Unwilling to provide stool samples\n* FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis\n* Prior history of colonoscopy within the past 5 years and removal of lesions\n* History of CRC\n* other conditions deemed not suited for the study by investigators"}, 'identificationModule': {'nctId': 'NCT04287335', 'acronym': 'CLEAR-C', 'briefTitle': 'Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients', 'orgStudyIdInfo': {'id': 'CLEAR-C 2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk CRC screening group', 'description': 'Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer', 'interventionNames': ['Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear', 'Diagnostic Test: FIT', 'Procedure: Colonoscopy']}, {'label': 'CRC group', 'description': 'Retrospective enrollment of subjects with confirmed colorectal cancer', 'interventionNames': ['Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear', 'Diagnostic Test: FIT', 'Procedure: Colonoscopy']}], 'interventions': [{'name': 'Multitarget stool FIT-DNA test - ColoClear', 'type': 'DIAGNOSTIC_TEST', 'description': 'Multitarget stool FIT-DNA test', 'armGroupLabels': ['CRC group', 'High risk CRC screening group']}, {'name': 'FIT', 'type': 'DIAGNOSTIC_TEST', 'description': 'fecal immunochemical test', 'armGroupLabels': ['CRC group', 'High risk CRC screening group']}, {'name': 'Colonoscopy', 'type': 'PROCEDURE', 'description': 'diagnostic colonoscopy', 'armGroupLabels': ['CRC group', 'High risk CRC screening group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': "Shanxi Provincial People's Hospital", 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Kefeng Ding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Horizon Health Technology Co., Ltd', 'class': 'UNKNOWN'}, {'name': 'Beijing Mingze Technology Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Ding Ke-Feng', 'investigatorAffiliation': 'Zhejiang University'}}}}