Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 325
- Locations
- 10
- Primary Endpoint
- Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
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 :
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •No health insurance ,
- •mental disability,
- •pregnancy
Arms & Interventions
Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention: qPCR diagnostic KIT of microRNAS (Device)
Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention: qPCR diagnostic KIT of microRNAS (Device)
RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention: qPCR diagnostic KIT of microRNAS (Device)
Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention: qPCR diagnostic KIT of microRNAS (Device)
Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention: qPCR diagnostic KIT of microRNAS (Device)
Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention: qPCR diagnostic KIT of microRNAS (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- - 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)