- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02020382
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases (MicroMICI)
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Clichy, Frankrig, 92110
- Hopital Beaujon
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Paris, Frankrig, 75010
- Hopital Saint Louis
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Paris, Frankrig, 75015
- Hôpital Necker Enfants malades
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Paris, Frankrig, 75012
- Hopital Saint Antoine
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Paris, Frankrig, 75019
- Hôpital Robert Deré
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Andet: RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Andet: Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Andet: Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Andet: Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Andet: Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
Tidsramme: 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
|
1 day
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
Tidsramme: 1 day
|
1 day
|
|
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
Tidsramme: 1 day
|
1 day
|
|
- Study the possibility of measuring miRNA of interest in feces and saliva
Tidsramme: 1 day
|
1 day
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Xavier Treton, MD,PhD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P120903
- 2013-A00310-45 (Anden identifikator: IDRCB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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