SASL Swiss Cirrhosis Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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SASL Swiss Cirrhosis Cohort Study

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic liver disease and histologically proven cirrhosis<br> | Other: Data collection<br>* Clinical assessment and blood sampling at day of inclusion and in 6- monthly intervals for stable cirrhotic patients; at day of inclusion and on days 3, 7, 14 and 28 for acute decompensation or acute-on-chronic liver failure patients; assessment of clinical, psychosocial/behavioural and patient-reported data in parallel with blood sampling; Biobanking of PBMCs and serum/plasma samples Biobanking of other biological material if sampled for clinical reasons (liver biopsies, ascites, urine, gut mucosa, lymph nodes)<br>|
| Control subjects with no signs of cirrhosis<br> | Other: Data collection<br>* Clinical assessment and blood sampling at day of inclusion and in 6- monthly intervals for stable cirrhotic patients; at day of inclusion and on days 3, 7, 14 and 28 for acute decompensation or acute-on-chronic liver failure patients; assessment of clinical, psychosocial/behavioural and patient-reported data in parallel with blood sampling; Biobanking of PBMCs and serum/plasma samples Biobanking of other biological material if sampled for clinical reasons (liver biopsies, ascites, urine, gut mucosa, lymph nodes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of liver transplantations | Change in Number of liver transplantations | Through study completion, an average of 10 years | 
| Change in Number of survival | Change in Number of survival | Through study completion, an average of 10 years | 
| Change in Number of transplant free survival | Change in Number of transplant free survival | Through study completion, an average of 10 years | 
| Change in Number of decompensation events | Change in Number of decompensation events | Through study completion, an average of 10 years | 
| Change in Number of organ failure | Change in Number of organ failure | Through study completion, an average of 10 years | 
| Change in Number of infectious complications | Change in Number of infectious complications | Through study completion, an average of 10 years | 
| Change in Number of maligancies | Change in Number of maligancies | Through study completion, an average of 10 years | 
| Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale) | 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) | Through study completion, an average of 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SASL Swiss Cirrhosis Cohort Study (SSciCoS), chronic liver disease