Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases

Not Applicable

Completed

• Conditions: Ulcerative Colitis; Crohn Disease; Non-IBD Colitis; Healthy
• Interventions: Device: qPCR diagnostic KIT of microRNAS

• Registration Number: NCT02020382
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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)

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

Not provided

Exclusion Criteria

• No health insurance ,
• mental disability,
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RCH adults	qPCR diagnostic KIT of microRNAS	testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Children with colitis	qPCR diagnostic KIT of microRNAS	testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Witnesses adults with non-IBD inflammation	qPCR diagnostic KIT of microRNAS	testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Witnesses healthy children	qPCR diagnostic KIT of microRNAS	testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Crohn adult colic	qPCR diagnostic KIT of microRNAS	testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Witnesses healthy adults	qPCR diagnostic KIT of microRNAS	testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health	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

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (5)

Hôpital Saint Louis; 🇫🇷 Paris, France

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Robert Deré; 🇫🇷 Paris, France

Hôpital Saint Antoine; 🇫🇷 Paris, France