Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
2 other identifiers
interventional
792
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2006
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2005
CompletedFirst Posted
Study publicly available on registry
October 28, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 28, 2009
January 1, 2009
2.6 years
October 26, 2005
January 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Cross-sectional prevalence of adenomas between the 2 study groups
Study Arms (1)
1
EXPERIMENTALChromocolonoscopy
Interventions
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
Eligibility Criteria
You may qualify if:
- Patients undergoing screening colonoscopy
You may not qualify if:
- Age \< 50
- Prior colon resection
- Inflammatory bowel disease
- Prior colonoscopy or sigmoidoscopy
- More than one first-degree relative with colon cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- American College of Gastroenterologycollaborator
- Stony Brook Universitycollaborator
- University of Chicagocollaborator
Study Sites (3)
Indiana University
Indianapolis, Indiana, 46202, United States
Roudebush VA Medical Center
Indianapolis, Indiana, United States
SUNY Stony Brook
Stony Brook, New York, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles J Kahi, MD
Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 26, 2005
First Posted
October 28, 2005
Study Start
May 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 28, 2009
Record last verified: 2009-01