SASL Swiss Cirrhosis Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 10
- 主要终点
- Change in Number of liver transplantations
研究概览
简要总结
This is a national prospective long-term multicentre observational cohort study following patients with cirrhosis in order to systematically and longitudinally record epidemiological, clinical, histological, psychosocial and patient-reported data and biobank biological material from patients with cirrhosis.
The central element of all scientific operation and productivity in the Swiss Cirrhosis Cohort Study (SSCiCoS) is the so-called "nested project" (NP). Based on the evolving large pool of data and biological samples, SSCiCoS investigators use the data pool in order to investigate specific hypotheses and questions.
详细描述
For patients with end-stage cirrhosis there are no treatment options other than transplantation, a medically and ethically challenging procedure. The challenge therefore is to prevent the need for liver transplantation in as many patients with cirrhosis as possible.
In order to reach this aim, patients with cirrhosis should be identified and followed regularly according to the highest standard of current knowledge. Numerous aspects of the disease need to be detailed: its epidemiology in Switzerland, its pathophysiology including the mechanism of scar tissue generation and resolution, the associated immune dysfunction and subsequent organ failures, disease related psychosocial and behavioural factors, perceived burden of liver cirrhosis in patients, diagnostic and prognostic biomarkers for disease dynamics, both progression and regression of disease, and stage-specific therapeutic strategies.
This is a national prospective long-term multicentre observational cohort study following patients with cirrhosis in order to systematically and longitudinally record epidemiological, clinical, histological, psychosocial and patient-reported data and biobank biological material from patients with cirrhosis.
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
- 是
入选标准
- •A) Patients with chronic liver disease and histologically proven cirrhosis
- •B) Control subjects with no signs of cirrhosis
排除标准
- •Age <18 years
- •patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)
结局指标
主要结局
Change in Number of liver transplantations
时间窗: Through study completion, an average of 10 years
Change in Number of liver transplantations
Change in Number of survival
时间窗: Through study completion, an average of 10 years
Change in Number of survival
Change in Number of maligancies
时间窗: Through study completion, an average of 10 years
Change in Number of maligancies
Change in Number of transplant free survival
时间窗: Through study completion, an average of 10 years
Change in Number of transplant free survival
Change in Number of decompensation events
时间窗: Through study completion, an average of 10 years
Change in Number of decompensation events
Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale)
时间窗: Through study completion, an average of 10 years
The Epworth Sleepiness Scale is a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the tendency to become sleepy on a scale of 0 (no chance of dozing) to 3 (high chance of dozing) is rated. (0 - 10: Normal range; 10 - 12: Borderline; 12 - 24: Abnormal)
Change in Number of organ failure
时间窗: Through study completion, an average of 10 years
Change in Number of organ failure
Change in Number of infectious complications
时间窗: Through study completion, an average of 10 years
Change in Number of infectious complications
次要结局
未报告次要终点