Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
NCT ID: NCT03308916
Last Updated: 2022-09-01
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
6500 participants
INTERVENTIONAL
2017-10-06
2035-10-30
Brief Summary
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Detailed Description
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The study goal is to evaluate the aptitude of transient elastography as a screening tool for advanced liver fibrosis, based on analyses of benefit, harm, detection rate, technical applicability and prognostic potential. Secondary aims are to compare novel serum markers of liver fibrosis as potential screening tools against transient elastography: The Enhanced Liver Fibrosis test, neoepitope markers of extracellular matrix turnover, cytokeratin-18 based markers and indirect indices of fibrosis from algorithms combining routine liver blood test. Screened participants with elevated liver stiffness (≥8.0 kiloPascal; estimated 400 participants with alcoholic liver disease, 400 participants with non-alcoholic fatty liver disease and 280 participants from the general population) will be investigated with 2-dimensional shear-wave elastography and abdominal ultrasonography and a liver biopsy to confirm or reject presence of advanced fibrosis.
All participants with a positive screening elastography will be invited for repeated liver stiffness measurements and serum fibrosis markers after a minimum of one year from inclusion.
Participants at risk of alcoholic and non-alcoholic liver disease, independent of liver stiffness measurement at inclusion, will be invited for repeated liver stiffness measurements and serum fibrosis markers after a minimum of one year from inclusion. At-risk participants with elevated liver stiffness measurements at a follow-up visit (\>6.0 kiloPascal) will be offered a liver biopsy, however no earlier than two years after the index biopsy.
All participants will be followed for 10 years to assess liver-related outcomes and all-course mortality.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Liver stiffness measurement
Transient elastography in fasting state
transient elastography
Ultrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis
Enhanced liver fibrosis test
Patented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1)
Indirect serum markers of liver fibrosis
Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT
Direct serum markers of liver fibrosis
Serum markers that reflect liver extracellular matrix turnover and -accumulation
LiverTRAIL
Software that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis.
Cytokeratin 18
Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65)
Omics markers
Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies
Interventions
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transient elastography
Ultrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis
Enhanced liver fibrosis test
Patented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1)
Indirect serum markers of liver fibrosis
Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT
Direct serum markers of liver fibrosis
Serum markers that reflect liver extracellular matrix turnover and -accumulation
LiverTRAIL
Software that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis.
Cytokeratin 18
Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65)
Omics markers
Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\[38\] OR
* Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol/L, HbA1c ≥48 mmol/mol, a random plasma glucose ≥11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol/L and/or 2 hour plasma glucose ≥11.1 mmol/L.
Exclusion Criteria
* 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.
In screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of:
* Contraindications for a percutaneous liver biopsy
* Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal.
* Hepatic congestion or bile duct dilation evidenced by ultrasound.
* Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.
30 Years
75 Years
ALL
No
Sponsors
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Horizon 2020 - European Commission
OTHER
Novo Nordisk A/S
INDUSTRY
University of Southern Denmark
OTHER
Esbjerg University Hospital of South-West Jutland
UNKNOWN
Odense Municipality Alcohol Rehabilitation Unit
UNKNOWN
Svendborg Municipality Alcohol Rehabilitation Unit
UNKNOWN
University of Copenhagen
OTHER
University of Oslo
OTHER
Nordic Bioscience A/S
INDUSTRY
VLV Bio, Peviva AB
UNKNOWN
Manatee APS
UNKNOWN
Siemens Healthcare A/S
INDUSTRY
Steno Diabetes Center Copenhagen
OTHER
Biomedical Research Foundation, Academy of Athens
OTHER
European Molecular Biology Laboratory, EMBL, University of Heidelberg
UNKNOWN
Maja Thiele
OTHER
Responsible Party
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Maja Thiele
Associate professor
Principal Investigators
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Maja Thiele, MD, PhD, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology and Hepatology, Odense University Hospital
Locations
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Department of Gastroenterology and Hepatology, Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Hansen CD, Hansen JK, Israelsen M, Andersen P, Pikkupeura LM, Lindvig KP, Stinson SE, Schnefeld HL, Tellerup J, Fogt M, Torp N, Kjaergaard M, Bech KT, Thorhauge KH, Johansen S, Spedtsberg I, Deluran E, Villesen IF, Detlefsen S, Hansen T, Krag A, Thiele M. Prevalence, severity and determinants of steatotic liver disease among individuals with metabolic and alcohol risk from the community. J Hepatol. 2025 Jul 5:S0168-8278(25)02319-0. doi: 10.1016/j.jhep.2025.06.020. Online ahead of print.
Kjaergaard M, Lindvig KP, Thorhauge KH, Andersen P, Hansen JK, Kastrup N, Jensen JM, Hansen CD, Johansen S, Israelsen M, Torp N, Trelle MB, Shan S, Detlefsen S, Antonsen S, Andersen JE, Graupera I, Gines P, Thiele M, Krag A. Using the ELF test, FIB-4 and NAFLD fibrosis score to screen the population for liver disease. J Hepatol. 2023 Aug;79(2):277-286. doi: 10.1016/j.jhep.2023.04.002. Epub 2023 Apr 21.
Other Identifiers
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S-20170087
Identifier Type: -
Identifier Source: org_study_id
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