Screening of Liver Fibrosis in Adults Without Known Liver Disease

NCT ID: NCT05486767

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-28

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Liver Fibrosis

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Community cohort

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

Transient elastography

Intervention Type 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)

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

Transient elastography

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FIB-4 score

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Bratislava

OTHER

Sponsor Role collaborator

University Hospital Kosice

UNKNOWN

Sponsor Role collaborator

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

OTHER

Sponsor Role lead

Responsible Party

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Ľubomír Skladaný MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Jarčuška, Prof

Role: STUDY_CHAIR

University Hospital Košice

Martin Janičko, MD, PhD

Role: STUDY_CHAIR

University hospital Košice

Tomáš Koller, MD, PhD

Role: STUDY_CHAIR

University Hospital Bratislava

Locations

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F.D.Roosevelt Teaching Hospital

Banská Bystrica, , Slovakia

Site Status

University Hospital Bratislava

Bratislava, , Slovakia

Site Status

Pasteur University Hospital

Košice, , Slovakia

Site Status

Countries

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Slovakia

Central Contacts

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Ľubomír Skladaný, MD, PhD

Role: CONTACT

905482997

Svetlana Dr Adamcová Selčanová, MD, PhD

Role: CONTACT

Facility Contacts

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Lubomir Skladany, MD, PhD

Role: primary

+421905482997

Natalia Bystrianska, MD

Role: backup

+421917944393

Tomas Koller, MD, PhD

Role: primary

+421905118692

Juraj Payer, Prof

Role: backup

+421905455079

Peter Jarčuška, Prof

Role: primary

0905899950

Martin Janičko, MD, PhD

Role: backup

0907178242

References

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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.

Reference Type BACKGROUND
PMID: 35854275 (View on PubMed)

Other Identifiers

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SIRIUS

Identifier Type: -

Identifier Source: org_study_id

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