Back to resultsChromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
Primary Purpose
Colon Cancer, Polyp, Adenoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chromocolonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer focused on measuring Colonoscopy, Chromoscopy, Prevention
Eligibility Criteria
Inclusion Criteria: Patients undergoing screening colonoscopy Exclusion Criteria: Age < 50 Prior colon resection Inflammatory bowel disease Prior colonoscopy or sigmoidoscopy More than one first-degree relative with colon cancer
Sites / Locations
- Indiana University
- Roudebush VA Medical Center
- SUNY Stony Brook
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Chromocolonoscopy
Outcomes
Primary Outcome Measures
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Secondary Outcome Measures
Full Information
NCT ID
NCT00245492
First Posted
October 26, 2005
Last Updated
January 27, 2009
Sponsor
Indiana University
Collaborators
American College of Gastroenterology, Stony Brook University, University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00245492
Brief Title
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
Official Title
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University
Collaborators
American College of Gastroenterology, Stony Brook University, University of Chicago
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Polyp, Adenoma
Keywords
Colonoscopy, Chromoscopy, Prevention
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
792 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Chromocolonoscopy
Intervention Type
Procedure
Intervention Name(s)
Chromocolonoscopy
Intervention Description
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
Primary Outcome Measure Information:
Title
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Time Frame
Cross-sectional prevalence of adenomas between the 2 study groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing screening colonoscopy
Exclusion Criteria:
Age < 50
Prior colon resection
Inflammatory bowel disease
Prior colonoscopy or sigmoidoscopy
More than one first-degree relative with colon cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles J Kahi, MD
Organizational Affiliation
Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
SUNY Stony Brook
City
Stony Brook
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
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