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| Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Ministry of Health, France Programme hospitalier de recherche clinique European Georges Pompidou Hospital |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00224601 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms, Hereditary Nonpolyposis |
Procedure: Colonoscopy with chromoscopy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Early Detection of Pre-Cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | October 2007 |
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.
Eligibility| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christophe CELLIER, Pr, MD, PhD | +33(0)-1 56 09 35 38 | christophe.cellier@egp.ap-hop-paris.fr |
| France, Ile De France | |
| Hopital Europeen Georges Pompidou | Recruiting |
| PARIS, Ile De France, France, 75015 | |
| Contact: Christophe CELLIER, Pr, MD, PhD (0)-1 56 09 35 38 christophe.cellier@egp.ap-hop-paris.fr | |
| Principal Investigator: | Christophe CELLIER, Pr,MD,PhD | Assistance Publique - Hôpitaux de Paris |
More Information
| Study ID Numbers: | P040423 |
| Study First Received: | September 16, 2005 |
| Last Updated: | July 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00224601 |
| Health Authority: | France: Ministry of Health |
|
Colorectal cancer HNPCC Diagnosis Coloscopy |
Chromoscopy Indigo carmine Colorectal Neoplasms Hereditary Nonpolyposis |
|
Digestive System Neoplasms Metabolic Diseases Gastrointestinal Diseases Colonic Diseases Hereditary nonpolyposis colon cancer Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Digestive System Diseases Neoplastic Syndromes, Hereditary Colorectal Neoplasms, Hereditary Nonpolyposis Genetic Diseases, Inborn Colorectal cancer, hereditary nonpolyposis, type 1 Gastrointestinal Neoplasms Metabolic disorder Colorectal Neoplasms |
|
Neoplasms Neoplasms by Site DNA Repair-Deficiency Disorders |
