Clinical Trials Directory

Trials / Completed

CompletedNCT00224601

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
25 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREColonoscopy with chromoscopy

Timeline

Start date
2005-07-01
Primary completion
2008-01-01
Completion
2008-01-01
First posted
2005-09-23
Last updated
2011-02-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00224601. Inclusion in this directory is not an endorsement.