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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663142
• Other study ID #: 09-API-02
• Status: Completed
• Start date: October 2010
• Est. completion date: December 2017

Study information

• Verified date: May 2010
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2017
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Flammatory Bowel Disease
• Recurrence

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	AP-HM	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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