SASL Swiss Cirrhosis Cohort

NCT06092385 | Recruiting

• 1 other identifier: 2022-01370; bb23Bernsmeier
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 10

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.

Conditions

Liver Cirrhosis

Keywords

SASL Swiss Cirrhosis Cohort Study (SSciCoS); chronic liver disease

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Patients with chronic liver disease and histologically proven cirrhosis

Other: Data collection

Control subjects with no signs of cirrhosis

Other: Data collection

Interventions

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; * 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; Patients with chronic liver disease and histologically proven cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• A) Patients with chronic liver disease and histologically proven cirrhosis
• B) Control subjects with no signs of cirrhosis

You may not qualify if:

• Age \<18 years
• patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (10)

Gastroenterology and Hepatology, Cantonal Hospital Ticino

Lugano, Canton Ticino, Switzerland

RECRUITING

University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland

Basel, 4031, Switzerland

RECRUITING

Department of Visceral Surgery and Medicine, University Hospital of Berne

Bern, Switzerland

NOT YET RECRUITING

Gastroenterology and Hepatology, University Hospital Geneva

Geneva, Switzerland

NOT YET RECRUITING

Gastroenterology and Hepatology, Lausanne University Hospital

Lausanne, Switzerland

RECRUITING

Ticino Liver Centre

Lugano, Switzerland

NOT YET RECRUITING

Gastroenterology and Hepatology, Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

NOT YET RECRUITING

Arud Centre for addiction medicine Zurich

Zurich, Switzerland

NOT YET RECRUITING

Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich

Zurich, Switzerland

NOT YET RECRUITING

Gastroenterology and Hepatology, University Hospital Zurich

Zurich, Switzerland

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christine Bernsmeier, Prof. Dr. med.

  University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Bernsmeier, Prof. Dr. med.

CONTACT

+41 61 265 2525; christine.bernsmeier@clarunis.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: June 4, 2024
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

CH (10)