Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM

Crohn's disease is a disease of complex etiology, multifactorial and still poorly understood. This disease, due to its morbidity and mortality, poses a significant public health problem in France. Apart from the involvement of bacterial factors and those involving the permeability of the epithelial barrier, it is now well recognized that several factors are associated with genetic predisposition in some of these patients. Among these factors, the Nod2 mutations were first identified. Studies concerning the presence of these mutations and the severity of disease results were sometimes conflicting. Very recently, new interesting mutations in genes involved in autophagy were found with greater frequency in patients with Crohn's disease. These mutations observed in Atg16 and IRGM genes. It has been particularly shown on large patient cohorts,the IRGM polymorphism was associated with a progressive disease, with histological severity scores. One of the severity criteria of Crohn's disease is the early recurrence observed in some patients after surgical resection of the injured segment. Predictive factors for such recurrence after surgery are not known or not.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Flammatory Bowel Disease

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Marseille, France, 13354
    • AP-HM
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Nice, France, 06202
    • Chu de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sick to benefit from ileal, colonic or ileocolic continuity with re Cohn proved a complicated disease (stenosis or fistula) or resistant to medical treatment well led

Description

Inclusion Criteria:

• Sick in whom endoscopic control six months after surgery is needed to assess the presence and severity of endoscopic recurrence in order to alter the medical management.
• Persons affiliated to the Social Security
• Persons who have signed informed consent

Exclusion Criteria:

• Patient not affiliated to social security
• Pregnant Women
• Persons participating in other clinical trials

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who receive surgical resection for intestinal in CD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Search for IRGM mutations and compare the frequency of these mutations.	Patients who receive surgical resection for intestinal MC have, within six months after surgery gastrointestinal endoscopy for judging the endoscopic recurrence and modify treatment if necessary. This quantifies the endoscopic recurrence of i0 to i4 classified according to the Rutgeerts score (45). Patients who have a score ≥ i2 have a severe endoscopic recurrence. We will compare the prevalence of sick with a score ≥ i2 in patient groups with or without mutation in the gene IRGM. The investigators will look for the existence of a mutation in the gene IRGM, Atg16 and IL23R. The mutation in the gene IRGM being the main prognostic factor, mutations in the genes IL23R Atg16 and prognostic factors constituting secondary.	6 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the prevalence of mutations IGRM in a prospective series of 200 patients operated	The prevalence of mutations IGRM, Atg16 and IL23 will be determined	6 months post surgery
Determine whether there are phenotypic characteristics of the disease associated with mutations of IGRM	The investigators will compare the frequency of postoperative recurrence in patients who have a mutation in the genes IL23 and Atg16	6 months post surgery
Determine whether there are pathological features associated with mutations of IGRM.	The investigators will determine if the main phenotypic characteristics of CD (age of onset, time between diagnosis and surgery, use of immunosuppressive and biologic therapies, smoking localization of the disease, etc..) Are associated with increased prevalence of mutations of IGRM, Atg16 and IL23R.	6 months post surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Xavier HEBUTERNE, PU-PH, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: August 6, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (Estimated): August 13, 2012

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Crohn's disease; gastrointestinal tract
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: 09-API-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No