Back to results

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

Primary Purpose

Colorectal Neoplasms, Hereditary Nonpolyposis

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Colonoscopy with chromoscopy

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms, Hereditary Nonpolyposis focused on measuring Colorectal cancer, HNPCC, Diagnosis, Coloscopy, Chromoscopy, Indigo carmine, Colorectal Neoplasms, Hereditary Nonpolyposis

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hopital Europeen Georges Pompidou

Outcomes

Primary Outcome Measures

Number of pre-cancer lesions or early cancer detected.

Secondary Outcome Measures

Anatomopathologic criteria (size of lesions, …).

Full Information

NCT ID

NCT00224601

First Posted

September 16, 2005

Last Updated

February 17, 2011

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00224601

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Hereditary Nonpolyposis

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Colonoscopy with chromoscopy

Primary Outcome Measure Information:

Title

Number of pre-cancer lesions or early cancer detected.

Time Frame

during the procedure

Secondary Outcome Measure Information:

Title

Anatomopathologic criteria (size of lesions, …).

Time Frame

during the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe CELLIER, Pr,MD,PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Europeen Georges Pompidou

City

Paris

State/Province

Ile de France

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

12949719

Citation

Mention JJ, Ben Ahmed M, Begue 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. doi: 10.1016/s0016-5085(03)01047-3.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs