Ulcerative ColitisMicroMICINCT02020382
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases
A study testing qPCR diagnostic KIT of microRNAS in people with Ulcerative Colitis and Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Healthy
- What is being tested?
- qPCR diagnostic KIT of microRNAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No health insurance ,
- mental disability,
- pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Beaujon
Clichy, 92110
Hôpital Saint Louis
Paris, 75010
Hôpital Saint Antoine
Paris, 75012
Hôpital Necker Enfants Malades
Paris, 75015
Hôpital Robert Deré
Paris, 75019
About this study
Official title: Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
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)
Read the 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
- Conditions
- Ulcerative Colitis, Crohn Disease, Healthy, Non-IBD Colitis
- Being tested
- qPCR diagnostic KIT of microRNAS
- Keywords
- microRNAs, IBD, Crohn's disease, Ulcerative colitis, colonic polyps screening, controls
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qPCR diagnostic KIT of microRNASDevice
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
| Study group | Role | What they receive |
|---|---|---|
| Crohn adult colic | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies Receives: Device: qPCR diagnostic KIT of microRNAS |
| RCH adults | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies Receives: Device: qPCR diagnostic KIT of microRNAS |
| Witnesses healthy adults | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies Receives: Device: qPCR diagnostic KIT of microRNAS |
| Witnesses adults with non-IBD inflammation | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies Receives: Device: qPCR diagnostic KIT of microRNAS |
| Children with colitis | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies Receives: Device: qPCR diagnostic KIT of microRNAS |
| Witnesses healthy children | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies Receives: Device: qPCR diagnostic KIT of microRNAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
Measured: 1 day
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
Measured: 1 day
- Study the possibility of measuring miRNA of interest in feces and saliva
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Treton, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020382
- Sponsor's protocol ID
- P120903
- Other IDs
- 2013-A00310-45
- Acronym
- MicroMICI
- Status last verified
- May 2018
- First submitted
- 9 Dec 2013
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02020382
- Acronym / sponsor ID
- MicroMICI / P120903
- Conditions
- Ulcerative Colitis, Crohn Disease, Healthy, Non-IBD Colitis
- Keywords
- microRNAs, IBD, Crohn's disease, Ulcerative colitis, colonic polyps screening, controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Crohn adult colic | Other | Device: qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies |
| RCH adults | Other | Device: qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies |
| Witnesses healthy adults | Other | Device: qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies |
| Witnesses adults with non-IBD inflammation | Other | Device: qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies |
| Children with colitis | Other | Device: qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies |
| Witnesses healthy children | Other | Device: qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- No health insurance ,
- mental disability,
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qPCR diagnostic KIT of microRNAStesting qPCR diagnostic KIT of microRNAS from colonic biopsies | Device | Children with colitis, Crohn adult colic, RCH adults, Witnesses adults with non-IBD inflammation, Witnesses healthy adults, Witnesses healthy children |
Primary outcome
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
3 secondary outcomes
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Treton, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qPCR diagnostic KIT of microRNAS in people with Ulcerative Colitis and Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.