Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00280332
Status:
COMPLETED
Last Update Posted:
2008-05-12
First Post:
2006-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-09', 'studyFirstSubmitDate': '2006-01-20', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of advanced colonic adenoma in the re-screening population', 'timeFrame': '5 year from index colonoscopy'}], 'secondaryOutcomes': [{'measure': 'The time to adenoma adenoma development according to different baseline characteristics of patients and colonoscopy findings', 'timeFrame': '5 years from index colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonic adenoma, colonic advanced neoplasm'], 'conditions': ['Colonic Cancer']}, 'descriptionModule': {'briefSummary': '* To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy\n* To determine the optimal time interval for re-screening in average risk individuals\n* To determine potential baseline characteristics that predicts adenoma recurrence', 'detailedDescription': 'Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown.\n\nThis study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who are previously participated in one of our two screening colonoscopy studies \\[Sung, Gastroenterol 2003; Leung, AJG 2004\\]', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are previously participated in one of our two screening colonoscopy studies \\[Sung, Gastroenterol 2003; Leung, AJG 2004\\]\n* Asymptomatic on first screening colonoscopy\n* Age\\>50and \\<75\n* No family history of CRC\n* No other colonoscopy except the baseline screening colonoscopy\n\nExclusion Criteria:\n\n* Subjects who refused consent\n* Subjects who are not warrant follow up colonoscopy'}, 'identificationModule': {'nctId': 'NCT00280332', 'briefTitle': 'A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy', 'orgStudyIdInfo': {'id': 'FUC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'colonic adenoma', 'interventionNames': ['Procedure: colonoscopy']}, {'label': 'B', 'description': 'colonic without adenoma', 'interventionNames': ['Procedure: colonoscopy']}], 'interventions': [{'name': 'colonoscopy', 'type': 'PROCEDURE', 'otherNames': ['follow up colonoscopy'], 'description': 'proform a follow up colonoscopy in the 5 year period from index colonoscopy', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong (sar)', 'country': 'China', 'facility': 'Endoscopy Center, Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Wai K Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUHK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr WK Leung', 'oldOrganization': 'Chinese University of Hong Kong'}}}}