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

NCT ID: NCT00245492

Last Updated: 2009-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

792 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Polyp Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Chromocolonoscopy

Group Type EXPERIMENTAL

Chromocolonoscopy

Intervention Type PROCEDURE

Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Interventions

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Chromocolonoscopy

Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American College of Gastroenterology

OTHER

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Indiana University

Principal Investigators

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Charles J Kahi, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Roudebush VA Medical Center

Indianapolis, Indiana, United States

Site Status

SUNY Stony Brook

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2005ACG-100CRC

Identifier Type: -

Identifier Source: secondary_id

0508-64

Identifier Type: -

Identifier Source: org_study_id

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