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)
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
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
325
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Hôpital Beaujon
Clichy, France
Hôpital Saint Louis
Paris, France
Hôpital Saint Antoine
Paris, France
Hôpital Necker Enfants Malades
Paris, France
Hôpital Robert Deré
Paris, France
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
Time frame: 1 day
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
Time frame: 1 day
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
Time frame: 1 day
- Study the possibility of measuring miRNA of interest in feces and saliva
Time frame: 1 day
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