Crohn Disease, Healthy, Non-IBD Colitis, Ulcerative Colitis
Conditions
Keywords
microRNAs, IBD, Crohn's disease, Ulcerative colitis, colonic polyps screening, controls
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
Interventions
DEVICEqPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Countries
France
Outcome results
None listed