- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02020382
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases (MicroMICI)
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Clichy, Frankrike, 92110
- Hopital Beaujon
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Paris, Frankrike, 75010
- Hopital Saint Louis
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Paris, Frankrike, 75015
- Hôpital Necker Enfants malades
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Paris, Frankrike, 75012
- Hopital Saint Antoine
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Paris, Frankrike, 75019
- Hôpital Robert Deré
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Annen: RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Annen: Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Annen: Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Annen: Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
Annen: Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Xavier Treton, MD,PhD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P120903
- 2013-A00310-45 (Annen identifikator: IDRCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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