Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 10
- 主要终点
- Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
研究概览
简要总结
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)
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •No health insurance ,
- •mental disability,
- •pregnancy
研究组 & 干预措施
Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
干预措施: qPCR diagnostic KIT of microRNAS (Device)
Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
干预措施: qPCR diagnostic KIT of microRNAS (Device)
RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
干预措施: qPCR diagnostic KIT of microRNAS (Device)
Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
干预措施: qPCR diagnostic KIT of microRNAS (Device)
Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
干预措施: qPCR diagnostic KIT of microRNAS (Device)
Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
干预措施: qPCR diagnostic KIT of microRNAS (Device)
结局指标
主要结局
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
时间窗: 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
次要结局
- - 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)