- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02878395
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases (PREDIPOSTOP)
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Adeline GERMAIN
- Email: a.germain@chru-nancy.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Crohn's disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gene expression profile in intestinal operative specimens
Time Frame: up to 2 months (from resection)
|
up to 2 months (from resection)
|
Methylation profile in intestinal operative specimens
Time Frame: up to 2 months (from resection)
|
up to 2 months (from resection)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Digestive symptoms
Time Frame: 6, 12, 24 months (after resection)
|
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
Time Frame: 6, 12, 24 months (after resection)
|
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
Time Frame: 6, 12, 24 months (after resection)
|
Rutgeerts criteria (recurrence when score >=i1)
|
6, 12, 24 months (after resection)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adeline GERMAIN, Service de Chirurgie Digestive, Hépatobiliaire, Endocrinienne et Cancérologique CHRU Nancy Brabois Adultes
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PJC 2014/MICI-GERMAIN/MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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