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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

Tracking Information
First Submitted Date  ICMJE December 9, 2013
First Posted Date  ICMJE December 24, 2013
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
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 ]
Change History Complete list of historical versions of study NCT02020382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • - Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults [ Time Frame: 1 day ]
  • Evaluate the diagnostic value of microRNAs in inflammatory colitis child [ Time Frame: 1 day ]
  • - Study the possibility of measuring miRNA of interest in feces and saliva [ Time Frame: 1 day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases
Official Title  ICMJE Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Ulcerative Colitis
  • Crohn Disease
  • Healthy
  • Non-IBD Colitis
Intervention  ICMJE Device: qPCR diagnostic KIT of microRNAS
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
Study Arms  ICMJE
  • Crohn adult colic
    testing qPCR diagnostic KIT of microRNAS from colonic biopsies
    Intervention: Device: qPCR diagnostic KIT of microRNAS
  • RCH adults
    testing qPCR diagnostic KIT of microRNAS from colonic biopsies
    Intervention: Device: qPCR diagnostic KIT of microRNAS
  • Witnesses healthy adults
    testing qPCR diagnostic KIT of microRNAS from colonic biopsies
    Intervention: Device: qPCR diagnostic KIT of microRNAS
  • Witnesses adults with non-IBD inflammation
    testing qPCR diagnostic KIT of microRNAS from colonic biopsies
    Intervention: Device: qPCR diagnostic KIT of microRNAS
  • Children with colitis
    testing qPCR diagnostic KIT of microRNAS from colonic biopsies
    Intervention: Device: qPCR diagnostic KIT of microRNAS
  • Witnesses healthy children
    testing qPCR diagnostic KIT of microRNAS from colonic biopsies
    Intervention: Device: qPCR diagnostic KIT of microRNAS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2017)
325
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
300
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020382
Other Study ID Numbers  ICMJE P120903
2013-A00310-45 ( Other Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xavier Treton, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP