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Recruiting NCT06092385

SASL Swiss Cirrhosis Cohort

— Observational Liver Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Liver Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

SASL Swiss Cirrhosis Cohort Study

Overview

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.

Interventions

  • 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, gu

Primary outcome measures

  • Change in Number of liver transplantations [Time frame: Through study completion, an average of 10 years]
  • Change in Number of survival [Time frame: Through study completion, an average of 10 years]
  • Change in Number of transplant free survival [Time frame: Through study completion, an average of 10 years]
  • Change in Number of decompensation events [Time frame: Through study completion, an average of 10 years]
  • Change in Number of organ failure [Time frame: Through study completion, an average of 10 years]
  • Change in Number of infectious complications [Time frame: Through study completion, an average of 10 years]
  • Change in Number of maligancies [Time frame: Through study completion, an average of 10 years]
  • Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale) [Time frame: Through study completion, an average of 10 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 10 centers
  • Gastroenterology and Hepatology, Cantonal Hospital Ticino — Lugano
  • University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Swit — Basel
  • Department of Visceral Surgery and Medicine, University Hospital of Berne — Bern
  • Gastroenterology and Hepatology, University Hospital Geneva — Geneva
  • Gastroenterology and Hepatology, Lausanne University Hospital — Lausanne
  • Ticino Liver Centre — Lugano
  • Gastroenterology and Hepatology, Cantonal Hospital St. Gallen — Sankt Gallen
  • Arud Centre for addiction medicine Zurich — Zurich
  • … and 2 more centers

Identifiers

NCT: NCT06092385 · 2022-01370; bb23Bernsmeier

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗