Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases

Study Overview
=================
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

Official Title
-----------------
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease

Conditions
-----------------
Healthy, Ulcerative Colitis, Crohn Disease, Non-IBD Colitis

Intervention / Treatment
-----------------
* Device: qPCR diagnostic KIT of microRNAS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, microRNAs, Crohn's disease, Ulcerative colitis, colonic polyps screening, controls