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Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

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ClinicalTrials.gov Identifier: NCT00245492
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : January 28, 2009
Information provided by:

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.

Condition or disease Intervention/treatment
Colon Cancer Polyp Adenoma Procedure: Chromocolonoscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
Study Start Date : May 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Procedure: Chromocolonoscopy
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. [ Time Frame: Cross-sectional prevalence of adenomas between the 2 study groups ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245492

United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Roudebush VA Medical Center
Indianapolis, Indiana, United States
United States, New York
SUNY Stony Brook
Stony Brook, New York, United States
Sponsors and Collaborators
Indiana University
American College of Gastroenterology
Stony Brook University
University of Chicago
Principal Investigator: Charles J Kahi, MD Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
More Information

Responsible Party: Charles Kahi, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00245492     History of Changes
Other Study ID Numbers: 0508-64
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Keywords provided by Indiana University:

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type