Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 4:13 PM
Study NCT ID:
NCT00245492
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2005-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 792}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2005-10-26', 'studyFirstSubmitQcDate': '2005-10-26', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.', 'timeFrame': 'Cross-sectional prevalence of adenomas between the 2 study groups'}]}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Chromoscopy', 'Prevention'], 'conditions': ['Colon Cancer', 'Polyp', 'Adenoma']}, 'descriptionModule': {'briefSummary': 'The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing screening colonoscopy\n\nExclusion Criteria:\n\n* Age \\< 50\n* Prior colon resection\n* Inflammatory bowel disease\n* Prior colonoscopy or sigmoidoscopy\n* More than one first-degree relative with colon cancer'}, 'identificationModule': {'nctId': 'NCT00245492', 'briefTitle': 'Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.', 'orgStudyIdInfo': {'id': '0508-64'}, 'secondaryIdInfos': [{'id': '2005ACG-100CRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Chromocolonoscopy', 'interventionNames': ['Procedure: Chromocolonoscopy']}], 'interventions': [{'name': 'Chromocolonoscopy', 'type': 'PROCEDURE', 'description': 'Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Roudebush VA Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Charles J Kahi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Gastroenterology', 'class': 'OTHER'}, {'name': 'Stony Brook University', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Charles Kahi, MD', 'oldOrganization': 'Indiana University'}}}}