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


Phase 2
25 Years
75 Years
Not Enrolling
Both
Colorectal Neoplasms, Hereditary Nonpolyposis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of pre-cancer lesions or early cancer detected.

Outcome Time Frame:

during the procedure

Safety Issue:

Yes

Principal Investigator

Christophe CELLIER, Pr,MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P040423

NCT ID:

NCT00224601

Start Date:

July 2005

Completion Date:

January 2008

Related Keywords:

  • Colorectal Neoplasms, Hereditary Nonpolyposis
  • Colorectal cancer
  • HNPCC
  • Diagnosis
  • Coloscopy
  • Chromoscopy
  • Indigo carmine
  • Colorectal Neoplasms
  • Hereditary Nonpolyposis
  • Neoplasms
  • Colorectal Neoplasms
  • Colorectal Neoplasms, Hereditary Nonpolyposis

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