Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases (MicroMICI)

May 18, 2018 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease

The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RATIONAL Inflammatory Bowel Disease (IBD) affects more than 200,000 people in France and 1.5 million in Europe. Difficulties in the management of IBD are related to the need for invasive tests for the diagnosis of IBD (endoscopy), partly explaining the delay in diagnosis, and the inability to distinguish early colonic Crohn's disease of ulcerative colitis (UC) in 10-30% of cases.

Recently, we identified real-time polymerase chain reaction (PCR), from healthy colonic mucosa of IBD patients, a molecular signature of IBD involving 10 microRNA (miRNA) Common (miR26a, miR29a, miR29b, miR126 * miR15a, miR127-3p, miR324 -3p, miR30c, miR185, miR196a) and 15 colic chronic disease (MC) and ulcerative colitis (RCH) discriminating microRNA (miR-142-3p, miR-142-5p, miR-146a, miR-146b-5p, miR150, miR-181d, miR-182, miR199a -3p, miR199a-5p, miR199b-5p, miR-203, miR223, miR-299-5p, miR320a, miR-328).

TYPE OF STUDY : multicenter diagnostic evaluation Study

MAIN PURPOSE OF THE STUDY : To evaluate the diagnostic value of microRNA in colonic IBD (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)

SECONDARY OBJECTIVES :

  • assess the ability of microRNA to discriminate a colic chronic disease (MC) of ulcerative colitis (RCH) in adults
  • evaluate the diagnostic value of microRNA in inflammatory colitis child
  • explore the possibility of measuring miRNA of interest in the stool

PRODUCTS OF THE STUDY diagnostic kit of IBD in quantitative polymerase chain reaction (qPCR)

NUMBER OF PATIENTS : 6 groups of 50 patients each will be included

  • Group 1: Crohn adult colic
  • Group 2: ulcerative colitis (RCH) adults
  • Group 3: Witnesses healthy adults
  • Group 4: Witnesses adults with non-IBD inflammation
  • Group 5: Children with colitis
  • Group 6 : Witnesses healthy children

INCLUSION LENGTH 30 months

DURATION OF THE STUDY 30 months

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Clichy, France, 92110
        • Hopital Beaujon
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75015
        • Hôpital Necker Enfants malades
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75019
        • Hôpital Robert Deré

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

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • Target Population : Patients (children and adults), man or woman, suffering from Crohn's disease with colonic involvement or ulcerative colitis according to the criteria of the European consensus (ECCO 2010)
  • Control population: healthy subjects and any non-Crohn's colitis or ulcerative colitis
  • Having a colonoscopy examination indication,
  • Who signed the consent form (for adults and signed parental consent obtained for patients minors)

Exclusion Criteria:

  • No health insurance ,
  • mental disability,
  • pregnancy

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Other: RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Other: Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Other: Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Other: Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Other: Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
Time Frame: 1 day
Evaluate the diagnostic value of microRNAs in qPCR, suitable for routine use, initially testing the expression of 25 miRNAs from endoscopic biopsies in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
Time Frame: 1 day
1 day
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
Time Frame: 1 day
1 day
- Study the possibility of measuring miRNA of interest in feces and saliva
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Xavier Treton, MD,PhD, Assistance Publique - Hôpitaux de Paris

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

December 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120903
  • 2013-A00310-45 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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