SASL Swiss Cirrhosis Cohort (SSCiCoS)

SASL Swiss Cirrhosis Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Other: Data collection

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Christine Bernsmeier, Prof. Dr. med.; Phone Number: +41 61 265 2525; Email: christine.bernsmeier@clarunis.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Centre for Gastrointestinal and Liver Diseases, University Hospital asel, Switzerland
    • Contact: Christine Bernsmeier, Prof. Dr. med.
    • Principal Investigator: Christine Bernsmeier, Prof. Dr. med.
  • Bern, Switzerland
    • Recruiting
    • Department of Visceral Surgery and Medicine, University Hospital of Berne
    • Contact: Annalisa Berzigotti, Prof. Dr. med.
    • Principal Investigator: Annalisa Berzigotti, Prof. Dr. med.
  • Geneva, Switzerland
    • Recruiting
    • Gastroenterology and Hepatology, University Hospital Geneva
    • Contact: Nicolas Goossens, PD Dr. med.
    • Principal Investigator: Nicolas Goossens, PD Dr. med.
  • Lausanne, Switzerland
    • Recruiting
    • Gastroenterology and Hepatology, Lausanne University Hospital
    • Contact: Montserrat Fraga, Dr. med.
    • Principal Investigator: Montserrat Fraga, Dr. med.
  • Lugano, Switzerland
    • Recruiting
    • Ticino Liver Centre
    • Contact: Andreas Cerny, Prof. Dr. med.
    • Principal Investigator: Andreas Cerny, Prof. Dr. med.
  • Saint Gallen, Switzerland
    • Recruiting
    • Gastroenterology and Hepatology, Cantonal Hospital St. Gallen
    • Contact: Patrizia Künzler, Dr. med.
    • Contact: David Semela, PD Dr. med.
    • Principal Investigator: Patrizia Künzler, Dr. med.
    • Principal Investigator: David Semela, PD Dr. med.
  • Zurich, Switzerland
    • Recruiting
    • Arud Centre for addiction medicine Zurich
    • Contact: Philip Bruggmann, PD Dr. med.
    • Principal Investigator: Philip Bruggmann, PD Dr. med.
  • Zurich, Switzerland
    • Recruiting
    • Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich
    • Contact: Joachim Mertens, PD Dr. med.
    • Principal Investigator: Joachim Mertens, PD Dr. med.
  • Zurich, Switzerland
    • Recruiting
    • Gastroenterology and Hepatology, University Hospital Zurich
    • Contact: Andreas Kremer, Prof. Dr. med.
    • Principal Investigator: Andreas Kremer, Prof. Dr. med.
  • Ticino
    • Lugano, Ticino, Switzerland
      • Recruiting
      • Gastroenterology and Hepatology, Cantonal Hospital Ticino
      • Contact: Andrea De Gottardi, Prof. Dr. med.
      • Principal Investigator: Andrea De Gottardi, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Christine Bernsmeier, Prof. Dr. med., University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: chronic liver disease; SASL Swiss Cirrhosis Cohort Study (SSciCoS)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 2022-01370; bb23Bernsmeier

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No