IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
研究概览
简要总结
Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
详细描述
Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).
Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .
Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=18 years
- •Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
- •Patients >=45 kg
- •Affiliated member of the Social Security system
排除标准
- •Patients with an undetermined colitis
- •Patients with a non established diagnosis of CD
- •Women of childbearing age without a method of contraception
- •Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
- •Pregnant women, breastfeeding women
- •- Age < 18 years
- •Persons under legal protection
- •Person who does not have the capacity to consent
- •Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).
结局指标
主要结局
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
时间窗: 5 years
次要结局
- Post-operative morbidity rates in IBD(5 years)
- Proportion of patients developing a cancer(5 years)
- Proportion of patients who underwent surgery(5 years)
- Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)(5 years)
- Readmission rates for acute severe colitis or ileitis(5 years)
- Surgical recurrent rate in Crohn's disease(5 years)
研究者
Dr Laurent PEYRIN-BIROULET
Doctor
Central Hospital, Nancy, France