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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RECRUITING
NA
408 participants
INTERVENTIONAL
2023-05-08
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Intervention
An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.
Transient Elastography
One transient elastography 1-2 weeks after randomization
Control
An invitation to screening by blood sampling with Fib-4
No interventions assigned to this group
Interventions
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Transient Elastography
One transient elastography 1-2 weeks after randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed written consent
Exclusion Criteria
* Severe liver disease (known by the participant)
18 Years
110 Years
ALL
No
Sponsors
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Novavi
UNKNOWN
Aarhus University Hospital
OTHER
Frederiksberg University Hospital
OTHER
University of Copenhagen
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Gro Askgaard, PHD
Role: PRINCIPAL_INVESTIGATOR
Zealand University Hospital
Locations
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Novavi Køge
Køge, , Denmark
Novavi Roskilde
Roskilde, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Dahlin P, Jepsen P, Molzen L, Madsen LG, Wegmann During S, Benthien KS, Winther-Jensen M, Grew JC, Kirk JW, Jensen KJ, Petersen J, Askgaard G. The Liver Care Trial: screening for liver disease in individuals attending treatment for alcohol use disorder-study protocol for a randomized controlled study. Trials. 2025 Oct 28;26(1):448. doi: 10.1186/s13063-025-09151-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SJ-995
Identifier Type: -
Identifier Source: org_study_id
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