SIRIUS: Screening of Liver Fibrosis in Adults Without Known Liver Disease

• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05486767
• Collaborator: University Hospital Bratislava (Other), University Hospital Kosice (Other)
• Enrollment: 1,000
• Locations: 3
• Anticipated Duration (Months): 16.1
• Patients Per Site: 333.3
• Patients Per Site Per Month: 20.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Liver Fibrosis	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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease
• Anticipated Study Start Date: Aug 28, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Liver fibrosis [August, 2022 - to September 2023]

   The amount of fibrous tissue in the liver according to non-invasive tests

Secondary Outcome Measures

1. Non-alcoholic fatty liver disease [August, 2022 - September, 2023]

   The amount of fat in the liver parenchyma by the non-invasive tests CAP and FLI

2. Alcohol associated liver disease [August, 2022 - September, 2023]

   Liver disease plus AUDIT score testimonyijng to the harmful alcohol use

3. Body mass index [August, 2022 - September, 2023]

   As calculated from height and weight (together with waist-to-hip ratio)

Other Outcome Measures

1. Gut microbiome dysbiosis [August, 2022 - September, 2023]

   Dysbiosis will be determined based on the alpha and beta diversity, followed by a the taxonomic analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	F.D.Roosevelt Teaching Hospital	Banska Bystrica		Slovakia	97401
2	University Hospital Bratislava	Bratislava		Slovakia	82101
3	Pasteur University Hospital	Košice		Slovakia	04018

Sponsors and Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• 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

Study Documents (Full-Text)

None provided.

More Information

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, 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.

• Responsible Party: Ľubomír Skladaný MD, PhD, MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• ClinicalTrials.gov Identifier: NCT05486767
• Other Study ID Numbers: SIRIUS
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ľubomír Skladaný MD, PhD, MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: Liver fibrosis; Screening; Non-alcoholic fatty liver disease; Alcohol associated liver disease
• Additional relevant MeSH terms: Liver Diseases; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis

Study Results

No Results Posted as of Aug 5, 2022