CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome
Phase 2
Completed
- Conditions
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Registration Number
- NCT00224601
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Patients with MLH1, MSH2 or MSH6 mutation.
- Patients concerned by early detection colonoscopy.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of pre-cancer lesions or early cancer detected. during the procedure
- Secondary Outcome Measures
Name Time Method Anatomopathologic criteria (size of lesions, …). during the procedure
Trial Locations
- Locations (1)
Hopital Europeen Georges Pompidou
🇫🇷Paris, Ile de France, France