Screening of Liver Fibrosis in Adults Without Known Liver Disease (SIRIUS)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Fibrosis
• Intervention / Treatment: Diagnostic test: Transient elastography

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ľubomír Skladaný, MD, PhD; Phone Number: 905482997; Email: lubomir.skladany@gmail.com
• Study Contact Backup: Name: Svetlana Dr Adamcová Selčanová, MD, PhD; Email: sselcanova@gmail.com

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • F.D.Roosevelt Teaching Hospital
  • Bratislava, Slovakia, 82101
    • University Hospital Bratislava
    • Contact: Tomas Koller, MD, PhD; Phone Number: +421905118692; Email: koller.tomas@gmail.com
    • Contact: Juraj Payer, Prof; Phone Number: +421905455079; Email: prof.payer@gmail.com
  • Košice, Slovakia, 04018
    • Pasteur University Hospital
    • Contact: Peter Jarčuška, Prof; Phone Number: 0905899950; Email: petjarc@yahoo.com
    • Contact: Martin Janičko, MD, PhD; Phone Number: 0907178242; Email: martin.janicko@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• adult, written informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Community cohort; SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations	Diagnostic test: Transient elastography; 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); Other Names: FIB-4 score
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	Diagnostic test: Transient elastography; 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); Other Names: FIB-4 score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver fibrosis	The amount of fibrous tissue in the liver according to non-invasive tests	August, 2022 - to September 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-alcoholic fatty liver disease	The amount of fat in the liver parenchyma by the non-invasive tests CAP and FLI	August, 2022 - September, 2023
Alcohol associated liver disease	Liver disease plus AUDIT score testimonyijng to the harmful alcohol use	August, 2022 - September, 2023
Body mass index	As calculated from height and weight (together with waist-to-hip ratio)	August, 2022 - September, 2023

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome dysbiosis	Dysbiosis will be determined based on the alpha and beta diversity, followed by a the taxonomic analysis	August, 2022 - September, 2023

Collaborators and Investigators

• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Collaborators: University Hospital Bratislava; University Hospital Kosice
• Investigators: Study Chair: Peter Jarčuška, Prof, University hospital Košice; Study Chair: Martin Janičko, MD, PhD, University hospital Košice; Study Chair: Tomáš Koller, MD, PhD, University Hospital Bratislava

Publications and helpful links

General 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, 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 28, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Non-alcoholic fatty liver disease; Screening; Liver fibrosis; Alcohol associated liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fatty Liver; Liver Diseases; Fibrosis; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: SIRIUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The whole dataset except will be shared with prof. Pere Ginés and the LiverScreen investigators
• IPD Sharing Time Frame: Data will be available as of December, 2023 - fo one year
• IPD Sharing Access Criteria: Consent of the SIRIUS principal investigator and chairs
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No