Swiss Primary Biliary Cholangitis Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Disease course
研究概览
简要总结
Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.
详细描述
Enrolment visit and one follow-up visit at least once a year are planned.
Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.
To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.
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
- •diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).
- •Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included
- •Patients/subjects aged at least 18 years and living in Switzerland are included
排除标准
- 未提供
结局指标
主要结局
Disease course
时间窗: 3 years
Observing disease course
Disease features
时间窗: 3 years
Observing disease features in Swiss population and see if they are similar to other countries'
Response to treatment
时间窗: 3 years
Observing response to treatment
Overall survival
时间窗: 3 years
Observing overall survival
Transplantation-free survival rate
时间窗: 3 years
Observing transplantation-free survival rate
次要结局
未报告次要终点