Clinical trial NCT06092385: SASL Swiss Cirrhosis Cohort
Official title: SASL Swiss Cirrhosis Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Keywords: SASL Swiss Cirrhosis Cohort Study (SSciCoS)
chronic liver disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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)

Primary outcomes:
measure: Change in Number of liver transplantations
timeFrame: Through study completion, an average of 10 years
measure: Change in Number of survival
timeFrame: Through study completion, an average of 10 years
measure: Change in Number of transplant free survival
timeFrame: Through study completion, an average of 10 years
measure: Change in Number of decompensation events
timeFrame: Through study completion, an average of 10 years
measure: Change in Number of organ failure
timeFrame: Through study completion, an average of 10 years
measure: Change in Number of infectious complications
timeFrame: Through study completion, an average of 10 years
measure: Change in Number of maligancies
timeFrame: Through study completion, an average of 10 years
measure: Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale)
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Gastroenterology and Hepatology, Cantonal Hospital Ticino
state: Ticino
city: Basel
country: Switzerland
facility: University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland
city: Bern
country: Switzerland
facility: Department of Visceral Surgery and Medicine, University Hospital of Berne
city: Geneva
country: Switzerland
facility: Gastroenterology and Hepatology, University Hospital Geneva
city: Lausanne
country: Switzerland
facility: Gastroenterology and Hepatology, Lausanne University Hospital
city: Lugano
country: Switzerland
facility: Ticino Liver Centre
city: Saint Gallen
country: Switzerland
facility: Gastroenterology and Hepatology, Cantonal Hospital St. Gallen
city: Zurich
country: Switzerland
facility: Arud Centre for addiction medicine Zurich
city: Zurich
country: Switzerland
facility: Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich
city: Zurich
country: Switzerland
facility: Gastroenterology and Hepatology, University Hospital Zurich
Study officials:
affiliation: University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland
name: Christine Bernsmeier, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: