Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Proportion of patients who succeed in their therapeutic strategy
研究概览
简要总结
The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease
详细描述
The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.
It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients over 18 years of age;
- •Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
- •Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
- •Patients who have given written consent to participate in the study and to keep biological samples for research purposes
排除标准
- •Patients refusing to participate in the cohort;
- •Patients with chronic inflammatory bowel disease quiescent at inclusion;
- •Patients with a contraindication to general anaesthesia;
- •Vulnerable patients (under court protection, curators, guardians);
结局指标
主要结局
Proportion of patients who succeed in their therapeutic strategy
时间窗: One year after inclusion
Determine the proportion of patients who succeed in their therapeutic strategy at one year
次要结局
未报告次要终点