SASL Swiss Cirrhosis Cohort

Recruiting

• Conditions: Liver Cirrhosis
• Interventions: Other: Data collection

• Registration Number: NCT06092385
• Lead Sponsor: University Hospital, Basel, Switzerland

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 Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2024-06
• Study Start: 2024-06-04
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2033-01
• Study Completion: 2033-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control subjects with no signs of cirrhosis	Data collection	-
Patients with chronic liver disease and histologically proven cirrhosis	Data collection	-

Primary Outcome Measures

Name	Time	Method
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 maligancies	Through study completion, an average of 10 years	Change in Number of maligancies
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 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)
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

Trial Locations

Locations (10)

Gastroenterology and Hepatology, Cantonal Hospital Ticino; 🇨🇭 Lugano, Ticino, Switzerland

University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland; 🇨🇭 Basel, Switzerland

Gastroenterology and Hepatology, University Hospital Geneva; 🇨🇭 Geneva, Switzerland

Gastroenterology and Hepatology, Lausanne University Hospital; 🇨🇭 Lausanne, Switzerland

Ticino Liver Centre; 🇨🇭 Lugano, Switzerland

Arud Centre for addiction medicine Zurich; 🇨🇭 Zurich, Switzerland

Department of Visceral Surgery and Medicine, University Hospital of Berne; 🇨🇭 Bern, Switzerland

Gastroenterology and Hepatology, Cantonal Hospital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Gastroenterology and Hepatology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich; 🇨🇭 Zurich, Switzerland