Clinical trial NCT05486767: Screening of Liver Fibrosis in Adults Without Known Liver Disease
Official title: Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Fibrosis
Keywords: Liver fibrosis
Screening
Non-alcoholic fatty liver disease
Alcohol associated liver disease
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
Collaborators: name: University Hospital Bratislava
name: University Hospital Kosice
First posted: 2022-08-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver fibrosis
timeFrame: August, 2022 - to September 2023
Secondary outcomes:
measure: Non-alcoholic fatty liver disease
timeFrame: August, 2022 - September, 2023
measure: Alcohol associated liver disease
timeFrame: August, 2022 - September, 2023
measure: Body mass index
timeFrame: August, 2022 - September, 2023
Other outcomes:
measure: Gut microbiome dysbiosis
timeFrame: August, 2022 - September, 2023
Locations:
city: Banska Bystrica
country: Slovakia
facility: F.D.Roosevelt Teaching Hospital
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Košice
country: Slovakia
facility: Pasteur University Hospital
Study officials:
affiliation: University Hospital Košice
name: Peter Jarčuška, Prof
role: STUDY_CHAIR
affiliation: University hospital Košice
name: Martin Janičko, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Bratislava
name: Tomáš Koller, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.