Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-04 @ 8:04 AM
Study NCT ID:
NCT03824418
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2018-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.', 'timeFrame': 'during surveillance colonoscopy', 'description': 'the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients in which at least one histological proven neoplastic lesion was detected', 'timeFrame': 'during surveillance colonoscopy', 'description': 'The proportion of patients in which at least one histological proven neoplastic lesion was detected'}, {'measure': 'The mean number of histological proven neoplastic lesions per patient', 'timeFrame': 'during surveillance colonoscopy', 'description': 'The mean number of histological proven neoplastic lesions per patient'}, {'measure': 'The proportion of patients in which at least one histological proven sessile serrated lesion was detected', 'timeFrame': 'during surveillance colonoscopy', 'description': 'The proportion of patients in which at least one histological proven sessile serrated lesion was detected'}, {'measure': 'The mean number of histological proven sessile serrated lesions per patient', 'timeFrame': 'during surveillance colonoscopy', 'description': 'The mean number of histological proven sessile serrated lesions per patient'}, {'measure': 'Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion', 'timeFrame': 'during surveillance colonoscopy', 'description': 'Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesions detected during surveillance colonoscopy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surveillance', 'Chromoendoscopy', 'Dysplasia', 'Ulcerative Colitis'], 'conditions': ['Ulcerative Colitis', 'Chromoendoscopy']}, 'descriptionModule': {'briefSummary': 'A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the FIND-UC trial that undergo a follow surveillance colonoscopy', 'eligibilityCriteria': 'Patients are eligible for inclusion in this study when they meet the following criteria:\n\nInclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n\\- Patients that where included in the previous FIND-UC trial\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Patients who not receive their surveillance colonoscopy with CE\n* Patients who not undergo their surveillance colonoscopy within 3 months of the surveillance recommendations\n\nWithdrawal of individual subjects\n\nA patient will be excluded from the study if any of the following events occur:\n\n* Withdrawal of informed consent\n* The patient requests to be discontinued from the study\n* The bowel preparation is scored as Boston Bowel Preparation Scale \\<6\n* Incomplete colonoscopy because the endoscopist is unable to intubate the cecum during the colonoscopy\n* The Mayo-score \\> 1 in at least in one of the bowel segments'}, 'identificationModule': {'nctId': 'NCT03824418', 'briefTitle': 'The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study', 'orgStudyIdInfo': {'id': '00001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chromoendoscopy follow-up', 'interventionNames': ['Procedure: Surveillance colonoscopy with chromoendoscopy']}, {'label': 'Autofluorescence follow-up', 'interventionNames': ['Procedure: Surveillance colonoscopy with chromoendoscopy']}], 'interventions': [{'name': 'Surveillance colonoscopy with chromoendoscopy', 'type': 'PROCEDURE', 'description': 'Surveillance colonoscopy with chromoendoscopy', 'armGroupLabels': ['Autofluorescence follow-up', 'Chromoendoscopy follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Prof. Evelien Dekker, MD, PhD', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}