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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00224601
First received: September 16, 2005
Last updated: February 17, 2011
Last verified: July 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of pre-cancer lesions or early cancer detected. [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anatomopathologic criteria (size of lesions, …). [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: July 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224601

Locations
France
Hopital Europeen Georges Pompidou
Paris, Ile de France, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christophe CELLIER, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Saliha DJANE, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00224601     History of Changes
Other Study ID Numbers: P040423
Study First Received: September 16, 2005
Last Updated: February 17, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colorectal cancer
HNPCC
Diagnosis
Coloscopy
 Chromoscopy
Indigo carmine
Colorectal Neoplasms
Hereditary Nonpolyposis

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013