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Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
Sponsor: Maja Thiele
Summary
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.
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
6500
Start Date
2017-10-06
Completion Date
2035-10-30
Last Updated
2022-09-01
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Department of Gastroenterology and Hepatology, Odense University Hospital
Odense, Denmark