CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome

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

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-01-31

Brief Summary

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The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

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Detailed Description

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Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the polyp are noted. The follow up were 1 month.

Conditions

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Colorectal Neoplasms, Hereditary Nonpolyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Colonoscopy with chromoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with MLH1, MSH2 or MSH6 mutation.
* Patients concerned by early detection colonoscopy.

Exclusion Criteria

* Coloscopy of tracking since less 1an
* occlusive Syndrome contra-indicating the preparation for a total coloscopies
* Colectomies
* medical Conditions or serious illnesses contra-indicating a coloscopy of screening
* pregnant Woman or nursing
* Anomaly of coagulation contra-indicating the realization of biopsies and/or the exeresis of the lesion colorectal

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No