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

Primary Purpose

Ulcerative Colitis, Crohn Disease, Healthy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
qPCR diagnostic KIT of microRNAS
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring microRNAs, IBD, Crohn's disease, Ulcerative colitis, colonic polyps screening, controls

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Beaujon
  • Hôpital Saint Louis
  • Hôpital Saint Antoine
  • Hôpital Necker Enfants Malades
  • Hôpital Robert Deré

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Crohn adult colic

RCH adults

Witnesses healthy adults

Witnesses adults with non-IBD inflammation

Children with colitis

Witnesses healthy children

Arm Description

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
- Study the possibility of measuring miRNA of interest in feces and saliva

Full Information

First Posted
December 9, 2013
Last Updated
May 18, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02020382
Brief Title
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases
Acronym
MicroMICI
Official Title
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn Disease, Healthy, Non-IBD Colitis
Keywords
microRNAs, IBD, Crohn's disease, Ulcerative colitis, colonic polyps screening, controls

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crohn adult colic
Arm Type
Other
Arm Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Arm Title
RCH adults
Arm Type
Other
Arm Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Arm Title
Witnesses healthy adults
Arm Type
Other
Arm Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Arm Title
Witnesses adults with non-IBD inflammation
Arm Type
Other
Arm Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Arm Title
Children with colitis
Arm Type
Other
Arm Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Arm Title
Witnesses healthy children
Arm Type
Other
Arm Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Intervention Type
Device
Intervention Name(s)
qPCR diagnostic KIT of microRNAS
Intervention Description
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Primary Outcome Measure Information:
Title
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
Description
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
Secondary Outcome Measure Information:
Title
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
Time Frame
1 day
Title
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
Time Frame
1 day
Title
- Study the possibility of measuring miRNA of interest in feces and saliva
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Treton, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Robert Deré
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases

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