SSCiCoS: SASL Swiss Cirrhosis Cohort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with chronic liver disease and histologically proven cirrhosis
|
Other: Data collection
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)
|
| Control subjects with no signs of cirrhosis
|
Other: Data collection
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)
|
Outcome Measures
Primary Outcome Measures
- Change in Number of liver transplantations [Through study completion, an average of 10 years]
Change in Number of liver transplantations
- Change in Number of survival [Through study completion, an average of 10 years]
Change in Number of survival
- Change in Number of transplant free survival [Through study completion, an average of 10 years]
Change in Number of transplant free survival
- Change in Number of decompensation events [Through study completion, an average of 10 years]
Change in Number of decompensation events
- Change in Number of organ failure [Through study completion, an average of 10 years]
Change in Number of organ failure
- Change in Number of infectious complications [Through study completion, an average of 10 years]
Change in Number of infectious complications
- Change in Number of maligancies [Through study completion, an average of 10 years]
Change in Number of maligancies
- Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale) [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Patients with chronic liver disease and histologically proven cirrhosis
-
- Control subjects with no signs of cirrhosis
Exclusion Criteria:
-
Age <18 years
-
patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gastroenterology and Hepatology, Cantonal Hospital Ticino | Lugano | Ticino | Switzerland | |
| 2 | University Centre for Gastrointestinal and Liver Diseases, University Hospital asel, Switzerland | Basel | Switzerland | 4031 | |
| 3 | Department of Visceral Surgery and Medicine, University Hospital of Berne | Bern | Switzerland | ||
| 4 | Gastroenterology and Hepatology, University Hospital Geneva | Geneva | Switzerland | ||
| 5 | Gastroenterology and Hepatology, Lausanne University Hospital | Lausanne | Switzerland | ||
| 6 | Ticino Liver Centre | Lugano | Switzerland | ||
| 7 | Gastroenterology and Hepatology, Cantonal Hospital St. Gallen | Saint Gallen | Switzerland | ||
| 8 | Arud Centre for addiction medicine Zurich | Zurich | Switzerland | ||
| 9 | Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich | Zurich | Switzerland | ||
| 10 | Gastroenterology and Hepatology, University Hospital Zurich | Zurich | Switzerland |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Christine Bernsmeier, Prof. Dr. med., University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-01370; bb23Bernsmeier