Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases (MicroMICI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Healthy; Non-IBD Colitis; Ulcerative Colitis; Crohn Disease

Treatments: Device: qPCR diagnostic KIT of microRNAS

Study type: Interventional

Funder types: Other

Identifiers

NCT02020382

P120903

2013-A00310-45 (Other Identifier)

Details and patient eligibility

About

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)

Full 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

Enrollment: 325 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

325 participants in 6 patient groups

Crohn adult colic

Other group

Description:

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Treatment:

Device: qPCR diagnostic KIT of microRNAS

RCH adults

Other group

Description:

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Treatment:

Device: qPCR diagnostic KIT of microRNAS

Witnesses healthy adults

Other group

Description:

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Treatment:

Device: qPCR diagnostic KIT of microRNAS

Witnesses adults with non-IBD inflammation

Other group

Description:

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Treatment:

Device: qPCR diagnostic KIT of microRNAS

Children with colitis

Other group

Description:

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Treatment:

Device: qPCR diagnostic KIT of microRNAS

Witnesses healthy children

Other group

Description:

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Treatment:

Device: qPCR diagnostic KIT of microRNAS