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NCT Number: NCT06092385

SASL Swiss Cirrhosis Cohort

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology and Hepatology, Cantonal Hospital Ticino, Lugano, Canton Ticino, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Primary outcomes

  1. Change in Number of liver transplantations

    Time frame: Through study completion, an average of 10 years

    Change in Number of liver transplantations

  2. Change in Number of survival

    Time frame: Through study completion, an average of 10 years

    Change in Number of survival

  3. Change in Number of transplant free survival

    Time frame: Through study completion, an average of 10 years

    Change in Number of transplant free survival

  4. Change in Number of decompensation events

    Time frame: Through study completion, an average of 10 years

    Change in Number of decompensation events

  5. Change in Number of organ failure

    Time frame: Through study completion, an average of 10 years

    Change in Number of organ failure

  6. Change in Number of infectious complications

    Time frame: Through study completion, an average of 10 years

    Change in Number of infectious complications

  7. Change in Number of maligancies

    Time frame: Through study completion, an average of 10 years

    Change in Number of maligancies

  8. Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Bernsmeier, Prof. Dr. med.

CONTACT

[email protected]

+41 61 265 2525

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

SASL Swiss Cirrhosis Cohort Study

Acronym: SSCiCoS

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Oct 23, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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