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

NCT ID: NCT02878395

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-01-31

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.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn's disease

Ileocolic resection

Intervention Type PROCEDURE

Interventions

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Ileocolic resection

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeline GERMAIN

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

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Adeline GERMAIN

Role: CONTACT

Other Identifiers

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PJC 2014/MICI-GERMAIN/MS

Identifier Type: -

Identifier Source: org_study_id

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