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

Assistance Publique - Hôpitaux de Paris1 site in 1 country80 target enrollmentJuly 2005

ConditionsColorectal Neoplasms, Hereditary Nonpolyposis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 80
Locations: 1
Primary Endpoint: Number of pre-cancer lesions or early cancer detected.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

January 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Eligibility Criteria

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