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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic liver disease and histologically proven cirrhosis |
| ||
| Control subjects with no signs of cirrhosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | 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;
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| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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The SSCiCoS enrols patients with chronic liver disease and histologically proven cirrhosis presenting at any of the participating centres. Additionally control subjects will be included who do not have evidence for the presence of cirrhosis. These control subjects may involve healthy controls as well as patients (pathological controls). In theory any adult subject with no suscpicion of cirrhosis, HCC or CCC may be included. The concomittent built-up of the control cohort is supposed to serve as control for the cirrhosis patients involved, thus specifically, but not exclusively healthy age-matched controls as well as pathological controls presenting with a pathology or events similar to the condition and/or complications of cirrhosis (e.g. chronic liver disease with no cirrhosis, non-cirrhotic portal hypertension, ascites, infection, gastrointestinal bleeding or acute kidney injury of other origin than cirrhosis).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Bernsmeier, Prof. Dr. med. | Contact | +41 61 265 2525 | christine.bernsmeier@clarunis.ch |
| Name | Affiliation | Role |
|---|---|---|
| Christine Bernsmeier, Prof. Dr. med. | University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology and Hepatology, Cantonal Hospital Ticino | Recruiting | Lugano | Canton Ticino | Switzerland |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Serum and plasma. Other biological material (e.g. ascites, urine, liver biopsies, liver resections, gut biopsies), sampled routinely for clinical reasons: stored for research purpose. Excess tissue will only be used for research purposes when the histopathology department has performed a full evaluation and no further tissue would be required for clinical diagnostic purposes. Liver or gut tissue will be used immediately, formalin-fixed and paraffin-embedded or snap-frozen and stored at -80°C. Also archived previously sampled tissue might be investigated in retrospect upon recruitment into the study. If possible, white blood cells from fluids (ascites, urine) will be separated by density centrifugation and either used immediately or stored at -140°C. The fluid supernatant will also be collected and stored at -80°C in de-centralised biobanking.
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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 |
| University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland | Recruiting | Basel | 4031 | Switzerland |
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| Department of Visceral Surgery and Medicine, University Hospital of Berne | Not yet recruiting | Bern | Switzerland |
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| Gastroenterology and Hepatology, University Hospital Geneva | Not yet recruiting | Geneva | Switzerland |
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| Gastroenterology and Hepatology, Lausanne University Hospital | Recruiting | Lausanne | Switzerland |
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| Ticino Liver Centre | Not yet recruiting | Lugano | Switzerland |
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| Gastroenterology and Hepatology, Cantonal Hospital St. Gallen | Not yet recruiting | Sankt Gallen | Switzerland |
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| Arud Centre for addiction medicine Zurich | Not yet recruiting | Zurich | Switzerland |
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| Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich | Not yet recruiting | Zurich | Switzerland |
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| Gastroenterology and Hepatology, University Hospital Zurich | Not yet recruiting | Zurich | Switzerland |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |