Clinical trial NCT02020382: Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases
Official title: Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Crohn Disease
Healthy
Non-IBD Colitis
Keywords: microRNAs
IBD
Crohn's disease
Ulcerative colitis
colonic polyps screening
controls
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 325
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility 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

Primary outcomes:
measure: Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
timeFrame: 1 day
Secondary outcomes:
measure: - Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
timeFrame: 1 day
measure: Evaluate the diagnostic value of microRNAs in inflammatory colitis child
timeFrame: 1 day
measure: - Study the possibility of measuring miRNA of interest in feces and saliva
timeFrame: 1 day
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Deré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Xavier Treton, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: