Screening of Liver Fibrosis in Adults Without Known Liver Disease

Liver Fibrosis Clinical Trial

— SIRIUS  

Official title:

Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486767
• Other study ID #: SIRIUS
• Status: Not yet recruiting
• Start date: August 28, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Contact: Lubomír Skladaný, MD, PhD
• Phone: 905482997
• Email: lubomir.skladany[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 outpatient clinics).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Non-alcoholic Fatty Liver Disease

Intervention

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)

Locations

Country	Name	City	State
Slovakia	F.D.Roosevelt Teaching Hospital	Banska Bystrica
Slovakia	University Hospital Bratislava	Bratislava
Slovakia	Pasteur University Hospital	Košice

Sponsors (3)

Lead Sponsor	Collaborator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica	University Hospital Bratislava, University Hospital Kosice

Country where clinical trial is conducted

Slovakia, 

References & Publications (1)

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, Hernández 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, Falcó JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Ginès 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiome dysbiosis	Dysbiosis will be determined based on the alpha and beta diversity, followed by a the taxonomic analysis	August, 2022 - September, 2023
Primary	Liver fibrosis	The amount of fibrous tissue in the liver according to non-invasive tests	August, 2022 - to September 2023
Secondary	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
Secondary	Alcohol associated liver disease	Liver disease plus AUDIT score testimonyijng to the harmful alcohol use	August, 2022 - September, 2023
Secondary	Body mass index	As calculated from height and weight (together with waist-to-hip ratio)	August, 2022 - September, 2023