Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:45 AM
Study NCT ID:
NCT07470658
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1274}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of advanced colorectal neoplasia (ACN)', 'timeFrame': '2 years', 'description': 'ACN is defined as colorectal cancer or advanced adenoma (adenoma ≥10 mm, villous histology, or high-grade dysplasia).'}], 'secondaryOutcomes': [{'measure': 'Detection rate of any adenoma', 'timeFrame': '2 years'}, {'measure': 'Detection rate of colorectal cancer', 'timeFrame': '2 years'}, {'measure': 'Screening compliance rate', 'timeFrame': '2 years'}, {'measure': 'Cost-effectiveness comparison between surveillance strategies', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Colorectal Cancer', 'Colo-rectal Cancer', 'Fecal Immunochemical Test']}, 'descriptionModule': {'briefSummary': 'Individuals with high fecal hemoglobin concentrations detected by fecal immunochemical testing (FIT) but negative findings on high-quality colonoscopy represent a clinically challenging population. Although colonoscopy is considered the gold standard diagnostic procedure, previous studies suggest that these individuals may still have an elevated long-term risk of colorectal cancer.\n\nThis randomized controlled trial aims to determine the optimal surveillance strategy for this high-risk group by comparing two approaches: repeat FIT testing after two years versus direct colonoscopy after two years.', 'detailedDescription': 'In colorectal cancer screening programs based on fecal immunochemical testing (FIT), a subgroup of individuals presents with strongly positive FIT results but negative findings on subsequent high-quality colonoscopy. Despite the absence of detected adenomas or cancer, these individuals may remain at increased risk of colorectal cancer.\n\nCurrently, there is no consensus guideline regarding the optimal follow-up strategy for this population. Some clinicians recommend repeat colonoscopy, while others prefer non-invasive monitoring using FIT.\n\nThis pragmatic randomized controlled trial will compare two surveillance strategies:\n\nRepeat FIT testing two years after enrollment\n\nDirect colonoscopy two years after enrollment\n\nThe primary objective is to compare the detection rate of advanced colorectal neoplasia (ACN) between the two strategies. The results of this study may help establish evidence-based surveillance guidelines for this high-risk population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Gastroenterology outpatient clinic at National Taiwan University Hospital and Cancer Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-74 years\n* Quantitative FIT result with fecal hemoglobin ≥100 µg/g within the past two years\n* Negative high-quality colonoscopy following the positive FIT result\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of colorectal cancer\n* Inflammatory bowel disease\n* Known hereditary colorectal cancer syndrome\n* Life expectancy less than five years\n* Inability or unwillingness to undergo colonoscopy'}, 'identificationModule': {'nctId': 'NCT07470658', 'briefTitle': 'Optimal Surveillance Strategy After Positive FIT and Negative Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'From Uncertainty to Evidence: A Randomized Controlled Trial for Optimal Surveillance in High-Risk Colonoscopy-Negative Individuals After Positive FIT', 'orgStudyIdInfo': {'id': '202508171RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FIT Surveillance', 'description': 'Participants will undergo repeat fecal immunochemical testing two years after enrollment. Colonoscopy will only be recommended if the repeat FIT result is positive.', 'interventionNames': ['Diagnostic Test: Colonoscopy Surveillance']}, {'label': 'Colonoscopy Surveillance', 'description': 'Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.', 'interventionNames': ['Diagnostic Test: Colonoscopy Surveillance']}], 'interventions': [{'name': 'Colonoscopy Surveillance', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will undergo direct colonoscopy two years after enrollment regardless of FIT results.', 'armGroupLabels': ['Colonoscopy Surveillance', 'FIT Surveillance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting Staff', 'investigatorFullName': 'National Taiwan University Clinical Trial Center', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}