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

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 2

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Treatments

Procedure: Colonoscopy with chromoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT00224601
P040423

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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