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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663142
First Posted: August 13, 2012
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose
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.

Condition
Flammatory Bowel Disease Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Postoperative Recurrence in Crohn's Disease: Predictors of Research Targeting the Constitutional Mutation of IRGM

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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

  • 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.


Biospecimen Retention:   Samples With DNA
Lesional tissue samples and healthy in cryotubes, taken from surgical specimens or biopsies.

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: December 2017
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients who receive surgical resection for intestinal in CD

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663142


Contacts
Contact: Xavier HEBUTERNE, PU-PH hebuterne.x@chu-nice.fr
Contact: Cassandre LANDES, Ingenior 0492034126 ext +33 landes.c@chu-nice.fr

Locations
France
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Bruno BONAZ, PU-PH         
Principal Investigator: Bruno BONAZ, PU-PH         
AP-HM Active, not recruiting
Marseille, France, 13354
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Michel VEYRAC, PH         
Principal Investigator: Michel VEYRAC, PH         
CHU de Nice Recruiting
Nice, France, 06202
Contact: Xavier HEBUTERNE, PU-PH       hebuterne.x@chu-nice.fr   
Principal Investigator: Xavier HEBUTERNE, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Director: Xavier HEBUTERNE, PU-PH CHU de Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01663142     History of Changes
Other Study ID Numbers: 09-API-02
First Submitted: August 6, 2012
First Posted: August 13, 2012
Last Update Posted: November 2, 2015
Last Verified: May 2010

Keywords provided by Centre Hospitalier Universitaire de Nice:
Crohn's disease
gastrointestinal tract

Additional relevant MeSH terms:
Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes