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

This study has been completed.
Sponsor:
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
  Purpose

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 Intervention
Colon Cancer
Polyp
Adenoma
Procedure: Chromocolonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 792
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chromocolonoscopy
Procedure: Chromocolonoscopy
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245492

Locations
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
Investigators
Principal Investigator: Charles J Kahi, MD Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
  More Information

No publications provided

Responsible Party: Charles Kahi, MD, Indiana University
ClinicalTrials.gov Identifier: NCT00245492     History of Changes
Other Study ID Numbers: 0508-64, 2005ACG-100CRC
Study First Received: October 26, 2005
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Colonoscopy
Chromoscopy
Prevention

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

ClinicalTrials.gov processed this record on September 18, 2014