Liver FibrosisSIRIUSNCT05486767
Screening of Liver Fibrosis in Adults Without Known Liver Disease
An observational study of Liver Fibrosis, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 3 sites in Slovakia.
Trial summary
SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or FIB-4 score (in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Transient elastography
- How many people
- 1,000 participants
- Where
- 3 sitesSlovakia
- Study dates
- 28 Aug 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: We will approach adults of any ethnicity and gender in a stable health-status without any diseases or with a chronic extra-hepatic disease/diseases which are at the time of exam compensated and under control for more than 2 months; any medication is acceptable. Primarily, we are interested in patients without any known history of registered liver disease, but patients with steatosis without known fibrosis or cirrhosis will be enrolled.
Who may be able to join
- adult, written informed consent
Who cannot join
- unable to provide sufficient reliable information for any reason
- withdrawal of the consent, anytime
- acute illness (e.g. febrile, drunk, on antibiotics, trauma, myocardial infarction < 2 months, operated on < 2 months, other)
- chronic disease interfering with the endpoint (malignancy < 2 years; decompensated chronic disease such as chronic heart disease with dyspnea New York heart Association NYHA 2+, Chronic obstructive pulmonary disease COPD GOLD B+, other)
- chronic liver disease other than non-alcoholic fatty liver disease without previous diagnosis of fibrosis
Trial locations and contacts
3 sites in 1 country.
Svetlana Dr Adamcová Selčanová, MD, PhD contact
Slovakia3 sites
F.D.Roosevelt Teaching Hospital
Banská Bystrica, 97401
Lubomir Skladany, MD, PhD, +421905482997, lubomir.skladany@gmail.com
Natalia Bystrianska, MD, +421917944393, naty2121@centrum.sk
University Hospital Bratislava
Bratislava, 82101
Tomas Koller, MD, PhD, +421905118692, koller.tomas@gmail.com
Juraj Payer, Prof, +421905455079, prof.payer@gmail.com
Pasteur University Hospital
Košice, 04018
Peter Jarčuška, Prof, 0905899950, petjarc@yahoo.com
Martin Janičko, MD, PhD, 0907178242, martin.janicko@gmail.com
About this study
Official title: Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease
SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or FIB-4 score (in outpatient clinics).
Read the detailed description
According to the Lancet Gastroenterology and Hepatology, Slovakia ranks at the top of the prevalence of liver cirrhosis in the world. Moreover, liver diseases are the leading cause of death in the age-group of 25 - 50 years-old. SIRIUS is the response conceived by the governing board of the Slovak society of hepatology with two main aims: to screen for liver fibrosis and to spread the largely unknown information in community, and primary-care sector.
- Conditions
- Liver Fibrosis
- Being tested
- Transient elastography
- Keywords
- Liver fibrosis, Screening, Non-alcoholic fatty liver disease, Alcohol associated liver disease
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient elastographyDiagnostic test
Also called FIB-4 score
Both tests belong to the group of non-invasive tests for liver fibrosis (transient elastography belongs to the imaging-based tests and FIB-4 to the blood-based tests)
| Study group | Role | What they receive |
|---|---|---|
| Community cohort | SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations Receives: Diagnostic Test: Transient elastography | |
| Outpatient cohort | Patients recruited during the elective / preventive examinations at the primary-care clinics or at other outpatient-clinics will have performed Hep-calculator for FIB-4 w/wo transient elastography Receives: Diagnostic Test: Transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fibrosis
The amount of fibrous tissue in the liver according to non-invasive tests
Measured: August, 2022 - to September 2023
Secondary outcomes (3)
Non-alcoholic fatty liver disease
The amount of fat in the liver parenchyma by the non-invasive tests CAP and FLI
Measured: August, 2022 - September, 2023
Alcohol associated liver disease
Liver disease plus AUDIT score testimonyijng to the harmful alcohol use
Measured: August, 2022 - September, 2023
Body mass index
As calculated from height and weight (together with waist-to-hip ratio)
Measured: August, 2022 - September, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start28 Aug 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bratislava, University Hospital Kosice
- Responsible party
- Principal investigator, Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Investigators
- Peter Jarčuška, Prof, Study chair, University Hospital KošiceMartin Janičko, MD, PhD, Study chair, University hospital KošiceTomáš Koller, MD, PhD, Study chair, University Hospital Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486767
- Sponsor's protocol ID
- SIRIUS
- Acronym
- SIRIUS
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The whole dataset except will be shared with prof. Pere Ginés and the LiverScreen investigators
Publications
Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6.
PubMed 35854275
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05486767
- Acronym / sponsor ID
- SIRIUS / SIRIUS
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Screening, Non-alcoholic fatty liver disease, Alcohol associated liver disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Collaborators
- University Hospital Bratislava, University Hospital Kosice
- Study start
- 28 Aug 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 4 Aug 2022 (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.
SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or FIB-4 score (in outpatient clinics).
Detailed description
According to the Lancet Gastroenterology and Hepatology, Slovakia ranks at the top of the prevalence of liver cirrhosis in the world. Moreover, liver diseases are the leading cause of death in the age-group of 25 - 50 years-old. SIRIUS is the response conceived by the governing board of the Slovak society of hepatology with two main aims: to screen for liver fibrosis and to spread the largely unknown information in community, and primary-care sector.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community cohort | – | Diagnostic Test: Transient elastographySIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations |
| Outpatient cohort | – | Diagnostic Test: Transient elastographyPatients recruited during the elective / preventive examinations at the primary-care clinics or at other outpatient-clinics will have performed Hep-calculator for FIB-4 w/wo transient elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will approach adults of any ethnicity and gender in a stable health-status without any diseases or with a chronic extra-hepatic disease/diseases which are at the time of exam compensated and under control for more than 2 months; any medication is acceptable. Primarily, we are interested in patients without any known history of registered liver disease, but patients with steatosis without known fibrosis or cirrhosis will be enrolled.
Key inclusion criteria (1 listed)
- adult, written informed consent
Key exclusion criteria (5 listed)
- unable to provide sufficient reliable information for any reason
- withdrawal of the consent, anytime
- acute illness (e.g. febrile, drunk, on antibiotics, trauma, myocardial infarction < 2 months, operated on < 2 months, other)
- chronic disease interfering with the endpoint (malignancy < 2 years; decompensated chronic disease such as chronic heart disease with dyspnea New York heart Association NYHA 2+, Chronic obstructive pulmonary disease COPD GOLD B+, other)
- chronic liver disease other than non-alcoholic fatty liver disease without previous diagnosis of fibrosis
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 |
|---|---|---|
| Transient elastographyAlso: FIB-4 scoreBoth tests belong to the group of non-invasive tests for liver fibrosis (transient elastography belongs to the imaging-based tests and FIB-4 to the blood-based tests) | Diagnostic test | Community cohort, Outpatient cohort |
Primary outcome
Liver fibrosis
Time frame: August, 2022 - to September 2023
The amount of fibrous tissue in the liver according to non-invasive tests
3 secondary outcomes
Non-alcoholic fatty liver disease
Time frame: August, 2022 - September, 2023
Alcohol associated liver disease
Time frame: August, 2022 - September, 2023
Body mass index
Time frame: August, 2022 - September, 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 35854275Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6.
- Individual participant dataSharing planned: Yes. The whole dataset except will be shared with prof. Pere Ginés and the LiverScreen investigators
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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. This study is not recruiting at the moment.
Svetlana Dr Adamcová Selčanová, MD, PhD contact
Peter Jarčuška, Prof study chair
University Hospital Košice
Martin Janičko, MD, PhD study chair
University hospital Košice
Tomáš Koller, MD, PhD study chair
University Hospital Bratislava
3 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 Fibrosis, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 3 sites in Slovakia.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovakia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ľubomír Skladaný, MD, PhD (905482997, lubomir.skladany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fibrosis (time frame: August, 2022 - to September 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486767, which also lists 1 linked publication.
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 5 Aug 2022.