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

NCT02878395 | Unknown

• 1 other identifier: PJC 2014/MICI-GERMAIN/MS
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Crohn Disease

Keywords

genomics; epigenomics; recurrence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Digestive symptoms

  6, 12, 24 months (after resection)

• Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients

  6, 12, 24 months (after resection)

• Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients

  6, 12, 24 months (after resection)

Study Arms (1)

Crohn's disease

Procedure: Ileocolic resection

Interventions

Ileocolic resection PROCEDURE

Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease needing an ileocolic resection at CHRU Nancy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Biospecimen

Retention: SAMPLES WITH DNA

Ileocolic resection with last loops of small intestine, colon portion and corresponding mesenteric-colic fat.

MeSH Terms

Conditions

Crohn Disease; Recurrence

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adeline GERMAIN

  Service de Chirurgie Digestive, Hépatobiliaire, Endocrinienne et Cancérologique CHRU Nancy Brabois Adultes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline GERMAIN

CONTACT

a.germain@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2021
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share