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

NCT ID: NCT00780949

Last Updated: 2012-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Crohn's Disease

Keywords

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Crohn's Disease, inflammatory bowel disease, Peyer's patches

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1: Crohn's disease patient

intestinal biopsies

Group Type EXPERIMENTAL

intestinal biopsies

Intervention Type OTHER

intestinal biopsies during routine endoscopy

Interventions

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intestinal biopsies

intestinal biopsies during routine endoscopy

Intervention Type OTHER

Other Intervention Names

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intestinal biopsies during routine endoscopy

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Pierre HUGOT, Professeur

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Robert Debre

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P071206

Identifier Type: -

Identifier Source: org_study_id