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RECRUITING
NCT03308916
NA

Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers

Sponsor: Maja Thiele

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

Indirect serum markers of liver fibrosis

Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT

DIAGNOSTIC_TEST

Direct serum markers of liver fibrosis

Serum markers that reflect liver extracellular matrix turnover and -accumulation

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

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