SASL Swiss Cirrhosis Cohort

Liver Cirrhosis Clinical Trial

— SSCiCoS  

Official title:

SASL Swiss Cirrhosis Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092385
• Other study ID #: 2022-01370; bb23Bernsmeier
• Status: Recruiting
• Start date: January 20, 2023
• Est. completion date: January 2033

Study information

• Verified date: October 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Christine Bernsmeier, Prof. Dr. med.
• Phone: +41 61 265 2525
• Email: christine.bernsmeier[@]clarunis.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 2033
• Est. primary completion date: January 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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)

Locations

Country	Name	City	State
Switzerland	University Centre for Gastrointestinal and Liver Diseases, University Hospital asel, Switzerland	Basel
Switzerland	Department of Visceral Surgery and Medicine, University Hospital of Berne	Bern
Switzerland	Gastroenterology and Hepatology, University Hospital Geneva	Geneva
Switzerland	Gastroenterology and Hepatology, Lausanne University Hospital	Lausanne
Switzerland	Gastroenterology and Hepatology, Cantonal Hospital Ticino	Lugano	Ticino
Switzerland	Ticino Liver Centre	Lugano
Switzerland	Gastroenterology and Hepatology, Cantonal Hospital St. Gallen	Saint Gallen
Switzerland	Arud Centre for addiction medicine Zurich	Zurich
Switzerland	Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich	Zurich
Switzerland	Gastroenterology and Hepatology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of liver transplantations	Change in Number of liver transplantations	Through study completion, an average of 10 years
Primary	Change in Number of survival	Change in Number of survival	Through study completion, an average of 10 years
Primary	Change in Number of transplant free survival	Change in Number of transplant free survival	Through study completion, an average of 10 years
Primary	Change in Number of decompensation events	Change in Number of decompensation events	Through study completion, an average of 10 years
Primary	Change in Number of organ failure	Change in Number of organ failure	Through study completion, an average of 10 years
Primary	Change in Number of infectious complications	Change in Number of infectious complications	Through study completion, an average of 10 years
Primary	Change in Number of maligancies	Change in Number of maligancies	Through study completion, an average of 10 years
Primary	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