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

August 22, 2016 updated by: Central Hospital, Nancy, France

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

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crohn's disease
Procedure: Ileocolic resection

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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Adeline GERMAIN, Service de Chirurgie Digestive, Hépatobiliaire, Endocrinienne et Cancérologique CHRU Nancy Brabois Adultes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

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)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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