Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
This study has been completed.
Sponsor:
Indiana University
Collaborators:
American College of Gastroenterology
Stony Brook University
University of Chicago
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00245492
First received: October 26, 2005
Last updated: January 27, 2009
Last verified: January 2009
| Tracking Information | |||||
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| First Received Date ICMJE | October 26, 2005 | ||||
| Last Updated Date | January 27, 2009 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. [ Time Frame: Cross-sectional prevalence of adenomas between the 2 study groups ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. | ||||
| Change History | Complete list of historical versions of study NCT00245492 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening. | ||||
| Official Title ICMJE | Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening. | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Chromocolonoscopy
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions. |
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| Study Arm (s) | Experimental: 1
Chromocolonoscopy
Intervention: Procedure: Chromocolonoscopy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 792 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00245492 | ||||
| Other Study ID Numbers ICMJE | 0508-64, 2005ACG-100CRC | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Charles Kahi, MD, Indiana University | ||||
| Study Sponsor ICMJE | Indiana University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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