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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00224601

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms, Hereditary Nonpolyposis	Procedure: Colonoscopy with chromoscopy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

Number of pre-cancer lesions or early cancer detected. [during the procedure]

Secondary Outcome Measures

Anatomopathologic criteria (size of lesions, …). [during the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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