Screening of Liver Fibrosis in Adults Without Known Liver Disease
NCT ID: NCT05486767
Last Updated: 2022-08-05
Study Results
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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UNKNOWN
1000 participants
OBSERVATIONAL
2022-08-28
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
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
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
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital Bratislava
OTHER
University Hospital Kosice
UNKNOWN
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
OTHER
Responsible Party
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Ľubomír Skladaný MD, PhD
MD, PhD
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
University Hospital Bratislava
Bratislava, , Slovakia
Pasteur University Hospital
Košice, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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SIRIUS
Identifier Type: -
Identifier Source: org_study_id
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