Immunological Consequences of CARD15/NOD2 Mutations in Crohn's Disease (PLAC)

August 2, 2012 updated by: Assistance Publique - Hôpitaux de Paris
The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Crohn's Disease (CD) affects about 60.000 to 80.000 people in France. It is characterised by a chronic or relapsing inflammation of the gut. Its aetiology is largely unknown, limiting the development of preventive and curative therapeutic options. In 2001, we have identified the first CD susceptibility gene: CARD15/NOD2. This gene is involved in the innate immune response but we do not know today how gene mutations may induce the disease lesions. However, many data suggest that the intestinal inflammation may be related with an abnormal function of the lymphoid tissue present in the gut.

The aim of the present proposal is to better understand the role of CARD15/NOD2 mutations (R702W, G908R and 1007fs) in the development and the function of the intestinal lymphoid tissue. 250 patients and controls will be enrolled at Robert Debré and Saint Louis Hospital (Paris, France) within a 2 years period.

For participant, 4 to 5 ileal biopsies will be taken during a routine colonoscopy. Patients will be classed in three groups according to their number of CARD15/NOD2 mutations (1) wild-type, 2) mutated heterozygotes and 3) mutated homozygotes or compound heterozygotes). A comparison between groups and with non inflammatory (colonoscopy performed for other reasons) or inflammatory (ulcerative colitis patients) controls will be done. For each group, cell phenotype, cytokine profile, permeability and bacterial translocation will be analysed on Peyer's patches.

The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Robert Debré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and adults ≥ 5 ans and ≤ 65 ans with a programmed routine colonoscopy for Crohn's disease, ulcerative colitis, or another benign gastroenterological disorder

Exclusion Criteria:

  • Patients < 5 ans or > 65 ans
  • Patients with contra-indications for multiple biopsies
  • Patients with an undeterminate colitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Crohn's disease patient
intestinal biopsies
Other: intestinal biopsies
intestinal biopsies during routine endoscopy
Other Names:
  • intestinal biopsies during routine endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cytokine production and cell phenotype in Peyer patches
Time Frame: final time frame at the end of the study
final time frame at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-Pierre HUGOT, Professeur, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P071206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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