Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome. Secondary objectives are to compare expression and methylation profiles according to: treatment response morphological (endoscopic and/or radiological) and clinical post-operating recurrence.

Detailed Description
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This aim of this study is to search for new biomarkers predictive of post-operating recurrence. At present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data. Predictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.

Official Title
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Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Procedure: Ileocolic resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies…), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data Patient undergoing ileocolic resection Patient affiliated to French social security Exclusion Criteria: Patient refusing sampling Patient with undetermined colitis Patient with non-confirmed diagnosis of inflammatory bowel disease Patient with inflammatory bowel disease not undergoing ileocolic resection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's disease<br> | Procedure: Ileocolic resection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression profile in intestinal operative specimens |  | up to 2 months (from resection) | 
| Methylation profile in intestinal operative specimens |  | up to 2 months (from resection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive symptoms | such as abdominal pain, Koenig syndrome (abdominal pain relieved by flatus or feces expulsion), diarrhea | 6, 12, 24 months (after resection) | 
| Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients | Koilakou score, recurrence when score >=1 | 6, 12, 24 months (after resection) | 
| Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients | Rutgeerts criteria (recurrence when score >=i1) | 6, 12, 24 months (after resection) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genomics, epigenomics, recurrence