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

Colorectal Neoplasms, Hereditary Nonpolyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224601
• Other study ID #: P040423
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: February 17, 2011
• Start date: July 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis

Intervention

Procedure:
• Colonoscopy with chromoscopy

Locations

Country	Name	City	State
France	Hopital Europeen Georges Pompidou	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Mention JJ, Ben Ahmed M, Bègue B, Barbe U, Verkarre V, Asnafi V, Colombel JF, Cugnenc PH, Ruemmele FM, McIntyre E, Brousse N, Cellier C, Cerf-Bensussan N. Interleukin 15: a key to disrupted intraepithelial lymphocyte homeostasis and lymphomagenesis in celiac disease. Gastroenterology. 2003 Sep;125(3):730-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pre-cancer lesions or early cancer detected.		during the procedure	Yes
Secondary	Anatomopathologic criteria (size of lesions, …).		during the procedure	Yes