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

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: Healthy; Crohn Disease; Ulcerative Colitis; Non-IBD Colitis
• Intervention / Treatment: Device: qPCR diagnostic KIT of microRNAS

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

6

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	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	1 day
Evaluate the diagnostic value of microRNAs in inflammatory colitis child	1 day
- Study the possibility of measuring miRNA of interest in feces and saliva	1 day

Collaborators and Investigators

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

Study record dates

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: microRNAs; IBD; Crohn's disease; Ulcerative colitis; colonic polyps screening; controls
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Colitis; Colitis, Ulcerative
• 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