- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02020382
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases (MicroMICI)
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Clichy, 프랑스, 92110
- Hopital Beaujon
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Paris, 프랑스, 75010
- Hopital Saint Louis
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Paris, 프랑스, 75015
- Hôpital Necker Enfants malades
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Paris, 프랑스, 75012
- Hopital Saint Antoine
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Paris, 프랑스, 75019
- Hôpital Robert Deré
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
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testing qPCR diagnostic KIT of microRNAS from colonic biopsies
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다른: RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
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testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
다른: Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
다른: Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
다른: Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
|
다른: Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
기간: 1 day
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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
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1 day
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
기간: 1 day
|
1 day
|
|
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
기간: 1 day
|
1 day
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- Study the possibility of measuring miRNA of interest in feces and saliva
기간: 1 day
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1 day
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Xavier Treton, MD,PhD, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .