Clinical trial NCT01663142: Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM
Official title: Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flammatory Bowel Disease
Crohn's Disease
Keywords: Crohn's disease
gastrointestinal tract
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Search for IRGM mutations and compare the frequency of these mutations.
timeFrame: 6 months post surgery
Secondary outcomes:
measure: To assess the prevalence of mutations IGRM in a prospective series of 200 patients operated
timeFrame: 6 months post surgery
measure: Determine whether there are phenotypic characteristics of the disease associated with mutations of IGRM
timeFrame: 6 months post surgery
measure: Determine whether there are pathological features associated with mutations of IGRM.
timeFrame: 6 months post surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Xavier HEBUTERNE, PU-PH
role: STUDY_DIRECTOR
References: