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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224601
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : February 18, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms, Hereditary Nonpolyposis Procedure: Colonoscopy with chromoscopy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Primary Outcome Measures :
  1. Number of pre-cancer lesions or early cancer detected. [ Time Frame: during the procedure ]

Secondary Outcome Measures :
  1. Anatomopathologic criteria (size of lesions, …). [ Time Frame: during the procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00224601

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

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Responsible Party: Saliha DJANE, Department of Clinical Research of developpement Identifier: NCT00224601    
Other Study ID Numbers: P040423
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: July 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Colorectal cancer
Indigo carmine
Colorectal Neoplasms
Hereditary Nonpolyposis
Additional relevant MeSH terms:
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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