Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases

Healthy Clinical Trial

— MicroMICI  

Official title:

Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020382
• Other study ID #: P120903
• Secondary ID: 2013-A00310-45
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Healthy
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Non-IBD Colitis
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy
France	Hôpital Necker Enfants Malades	Paris
France	Hôpital Robert Deré	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults		1 day
Secondary	Evaluate the diagnostic value of microRNAs in inflammatory colitis child		1 day
Secondary	- Study the possibility of measuring miRNA of interest in feces and saliva		1 day