Liver CirrhosisSSCiCoSNCT06092385
SASL Swiss Cirrhosis Cohort
An observational study of Liver Cirrhosis, run by University Hospital, Basel, Switzerland at 10 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Data collection
- How many people
- 3,000 participants
- Where
- 10 sitesSwitzerland
- Study dates
- 4 Jun 2024to Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- A) Patients with chronic liver disease and histologically proven cirrhosis
- B) Control subjects with no signs of cirrhosis
Who cannot join
- Age <18 years
- patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Switzerland10 sites, 10 recruiting
- Recruiting
University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland
Basel, 4031
Christine Bernsmeier, Prof. Dr. med.
Christine Bernsmeier, Prof. Dr. med.
- Not yet recruiting
Department of Visceral Surgery and Medicine, University Hospital of Berne
Bern
Annalisa Berzigotti, Prof. Dr. med.
Annalisa Berzigotti, Prof. Dr. med.
- Not yet recruiting
Gastroenterology and Hepatology, University Hospital Geneva
Geneva
Nicolas Goossens, PD Dr. med.
Nicolas Goossens, PD Dr. med.
- Recruiting
Gastroenterology and Hepatology, Lausanne University Hospital
Lausanne
Montserrat Fraga, Dr. med.
Montserrat Fraga, Dr. med.
- Recruiting
Gastroenterology and Hepatology, Cantonal Hospital Ticino
Lugano, Canton Ticino
Andrea De Gottardi, Prof. Dr. med.
Andrea De Gottardi, Prof. Dr. med.
- Not yet recruiting
Ticino Liver Centre
Lugano
Andreas Cerny, Prof. Dr. med.
Andreas Cerny, Prof. Dr. med.
- Not yet recruiting
Gastroenterology and Hepatology, Cantonal Hospital St. Gallen
Sankt Gallen
Patrizia Künzler, Dr. med.
David Semela, PD Dr. med.
- Not yet recruiting
Arud Centre for addiction medicine Zurich
Zurich
Philip Bruggmann, PD Dr. med.
Philip Bruggmann, PD Dr. med.
- Not yet recruiting
Digestive Diseases Insti- tute GastroZentrum, Hirslanden Clinic Zurich
Zurich
Joachim Mertens, PD Dr. med.
Joachim Mertens, PD Dr. med.
- Not yet recruiting
Gastroenterology and Hepatology, University Hospital Zurich
Zurich
Andreas Kremer, Prof. Dr. med.
Andreas Kremer, Prof. Dr. med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Data collection
- Keywords
- SASL Swiss Cirrhosis Cohort Study (SSciCoS), chronic liver disease
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic liver disease and histologically proven cirrhosis | Not described Receives: Other: Data collection | |
| Control subjects with no signs of cirrhosis | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of liver transplantations
Change in Number of liver transplantations
Measured: Through study completion, an average of 10 years
Change in Number of survival
Change in Number of survival
Measured: Through study completion, an average of 10 years
Change in Number of transplant free survival
Change in Number of transplant free survival
Measured: Through study completion, an average of 10 years
Change in Number of decompensation events
Change in Number of decompensation events
Measured: Through study completion, an average of 10 years
Change in Number of organ failure
Change in Number of organ failure
Measured: Through study completion, an average of 10 years
Change in Number of infectious complications
Change in Number of infectious complications
Measured: Through study completion, an average of 10 years
Change in Number of maligancies
Change in Number of maligancies
Measured: 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)
Measured: Through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start4 Jun 2024
- Primary completionJan 2033 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Bernsmeier, Prof. Dr. med., Principal investigator, University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092385
- Sponsor's protocol ID
- 2022-01370; bb23Bernsmeier
- Acronym
- SSCiCoS
- Status last verified
- Jul 2025
- First submitted
- 9 Oct 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SASL Swiss Cirrhosis Cohort Study
- ClinicalTrials.gov ID
- NCT06092385
- Acronym / sponsor ID
- SSCiCoS / 2022-01370; bb23Bernsmeier
- Conditions
- Liver Cirrhosis
- Keywords
- SASL Swiss Cirrhosis Cohort Study (SSciCoS), chronic liver disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic liver disease and histologically proven cirrhosis | – | Other: Data collection |
| Control subjects with no signs of cirrhosis | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- A) Patients with chronic liver disease and histologically proven cirrhosis
- B) Control subjects with no signs of cirrhosis
Key exclusion criteria (2 listed)
- Age <18 years
- patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionClinical 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) | Other | Control subjects with no signs of cirrhosis, Patients with chronic liver disease and histologically proven cirrhosis |
Primary outcome
Change in Number of liver transplantations
Time frame: Through study completion, an average of 10 years
Change in Number of liver transplantations
Change in Number of survival
Time frame: Through study completion, an average of 10 years
Change in Number of survival
Change in Number of transplant free survival
Time frame: Through study completion, an average of 10 years
Change in Number of transplant free survival
Change in Number of decompensation events
Time frame: Through study completion, an average of 10 years
Change in Number of decompensation events
Change in Number of organ failure
Time frame: Through study completion, an average of 10 years
Change in Number of organ failure
Change in Number of infectious complications
Time frame: Through study completion, an average of 10 years
Change in Number of infectious complications
Change in Number of maligancies
Time frame: Through study completion, an average of 10 years
Change in Number of maligancies
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Bernsmeier, Prof. Dr. med. principal investigator
University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Switzerland
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by University Hospital, Basel, Switzerland at 10 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Bernsmeier, Prof. Dr. med. (+41 61 265 2525, christine.bernsmeier@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of liver transplantations (time frame: Through study completion, an average of 10 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.