Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorMaja Thiele
About this trial
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.
Eligibility criteria
Qualifiers
Age 30-75 years (except the general population, which should be aged 40-75)
Informed consent to study investigations
Ability to read and write Danish AND (only at-risk patients)
Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR
Disqualifiers
Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding.
Known concurrent liver disease other than ALD and NAFLD.
Cancer or other debilitating disease with an expected survival of less than 12 months.
Inability to comply with the study protocol.
Trial design
Treatments tested in this trial
- transient elastography
- Enhanced liver fibrosis test
- Indirect serum markers of liver fibrosis
- Direct serum markers of liver fibrosis
- LiverTRAIL
- Cytokeratin 18
- Omics markers
Treatment groups
6,500 Participants
are divided into 1 treatment groupSponsors and collaborators
Maja Thiele
Lead sponsor
Odense University Hospital
Sponsor institution
Horizon 2020 - European Commission
Collaborator
Novo Nordisk A/S
Collaborator
University of Southern Denmark
Collaborator
Esbjerg University Hospital of South-West Jutland
Collaborator
Odense Municipality Alcohol Rehabilitation Unit
Collaborator
Svendborg Municipality Alcohol Rehabilitation Unit
Collaborator
University of Copenhagen
Collaborator
University of Oslo
Collaborator
Nordic Bioscience A/S
Collaborator
VLV Bio, Peviva AB
Collaborator
Manatee APS
Collaborator
Siemens Healthcare A/S
Collaborator
Steno Diabetes Center Copenhagen
Collaborator
Biomedical Research Foundation, Academy of Athens
Collaborator
Heidelberg University
Collaborator
Source ClinicalTrials.gov