Screening of Liver Fibrosis in Adults Without Known Liver Disease

NCT05486767 | Unknown

• 1 other identifier: SIRIUS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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).

Conditions

Liver Fibrosis

Keywords

Liver fibrosis; Screening; Non-alcoholic fatty liver disease; Alcohol associated liver disease

Outcome Measures

Primary Outcomes (1)

• Liver fibrosis

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

  August, 2022 - to September 2023

Secondary Outcomes (3)

• Non-alcoholic fatty liver disease

  August, 2022 - September, 2023

• Alcohol associated liver disease

  August, 2022 - September, 2023

• Body mass index

  August, 2022 - September, 2023

Other Outcomes (1)

• Gut microbiome dysbiosis

  August, 2022 - September, 2023

Study Arms (2)

Community cohort

SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations

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

Diagnostic Test: Transient elastography

Interventions

Transient elastography DIAGNOSTIC_TEST

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)

Also known as: FIB-4 score

Community cohort; Outpatient cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adult, written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: lead
• University Hospital Bratislava: collaborator
• University Hospital Kosice: collaborator

Study Sites (3)

F.D.Roosevelt Teaching Hospital

Banská Bystrica, 97401, Slovakia

Location

University Hospital Bratislava

Bratislava, 82101, Slovakia

Location

Pasteur University Hospital

Košice, 04018, Slovakia

Location

Related 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, 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.

  PMID: 35854275 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool sample for microbiome analysis by 16S RNA

MeSH Terms

Conditions

Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver

Study Officials

• 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 CHAIR

Central Study Contacts

Ľubomír Skladaný, MD, PhD

CONTACT

905482997; lubomir.skladany@gmail.com

Svetlana Dr Adamcová Selčanová, MD, PhD

CONTACT

sselcanova@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 28, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 30, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available as of December, 2023 - fo one year
• Access Criteria: Consent of the SIRIUS principal investigator and chairs

Locations

SL (3)