SASL Swiss Cirrhosis Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 10
- Primary Endpoint
- Change in Number of liver transplantations
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A) Patients with chronic liver disease and histologically proven cirrhosis
- •B) Control subjects with no signs of cirrhosis
Exclusion Criteria
- •Age <18 years
- •patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)
Outcomes
Primary Outcomes
Change in Number of liver transplantations
Time Frame: Through study completion, an average of 10 years
Change in Number of liver transplantations
Change in Number of survival
Time Frame: Through study completion, an average of 10 years
Change in Number of survival
Change in Number of maligancies
Time Frame: Through study completion, an average of 10 years
Change in Number of maligancies
Change in Number of transplant free survival
Time Frame: Through study completion, an average of 10 years
Change in Number of transplant free survival
Change in Number of decompensation events
Time Frame: 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)
Time Frame: 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
Time Frame: Through study completion, an average of 10 years
Change in Number of organ failure
Change in Number of infectious complications
Time Frame: Through study completion, an average of 10 years
Change in Number of infectious complications
Secondary Outcomes
No secondary outcomes reported