NCT02020382

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

December 9, 2013

Last Update Submit

May 18, 2018

Conditions

Ulcerative ColitisCrohn DiseaseHealthyNon-IBD Colitis

Keywords

microRNAsIBDCrohn's diseaseUlcerative colitiscolonic polyps screeningcontrols

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • - Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults

    1 day

  • Evaluate the diagnostic value of microRNAs in inflammatory colitis child

    1 day

  • - Study the possibility of measuring miRNA of interest in feces and saliva

    1 day

Study Arms (6)

Crohn adult colic

OTHER

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Device: qPCR diagnostic KIT of microRNAS

RCH adults

OTHER

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Device: qPCR diagnostic KIT of microRNAS

Witnesses healthy adults

OTHER

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Device: qPCR diagnostic KIT of microRNAS

Witnesses adults with non-IBD inflammation

OTHER

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Device: qPCR diagnostic KIT of microRNAS

Children with colitis

OTHER

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Device: qPCR diagnostic KIT of microRNAS

Witnesses healthy children

OTHER

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Device: qPCR diagnostic KIT of microRNAS

Interventions

qPCR diagnostic KIT of microRNASDEVICE

testing qPCR diagnostic KIT of microRNAS from colonic biopsies

Children with colitisCrohn adult colicRCH adultsWitnesses adults with non-IBD inflammationWitnesses healthy adultsWitnesses healthy children

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • No health insurance ,
  • mental disability,
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Hôpital Robert Deré

Paris, 75019, France

Location

MeSH Terms

Conditions

Colitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Xavier Treton, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 24, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

FR(5)