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

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ClinicalTrials.gov Identifier: NCT02020382
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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)

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn Disease Healthy Non-IBD Colitis Device: qPCR diagnostic KIT of microRNAS Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies




Primary Outcome Measures :
  1. Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health [ Time Frame: 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 Outcome Measures :
  1. - Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults [ Time Frame: 1 day ]
  2. Evaluate the diagnostic value of microRNAs in inflammatory colitis child [ Time Frame: 1 day ]
  3. - Study the possibility of measuring miRNA of interest in feces and saliva [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020382


Locations
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France
Hôpital Beaujon
Clichy, France, 92110
Hôpital Saint Louis
Paris, France, 75010
Hôpital Saint Antoine
Paris, France, 75012
Hôpital Necker Enfants Malades
Paris, France, 75015
Hôpital Robert Deré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Xavier Treton, MD,PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02020382     History of Changes
Other Study ID Numbers: P120903
2013-A00310-45 ( Other Identifier: IDRCB )
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
microRNAs
IBD
Crohn's disease
Ulcerative colitis
colonic polyps screening
controls
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes