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Completed

NCT Number: NCT00224601

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

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.

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Key information

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Europeen Georges Pompidou

Paris, Île-de-France Region, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonoscopy with chromoscopy

Procedure

Primary outcomes

  1. Number of pre-cancer lesions or early cancer detected.

    Time frame: during the procedure

Secondary outcomes

  1. Anatomopathologic criteria (size of lesions, …).

    Time frame: during the procedure

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 23, 2005
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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