RecruitingNot ApplicableNCT03308916

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

Sponsor

Maja Thiele

Enrollment

6,500 participants

Start Date

Oct 6, 2017

Study Type

INTERVENTIONAL

Conditions

Fibrosis Liver Diseases, Alcoholic

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.

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cytokeratin 18, Direct serum markers of liver fibrosis, and others for people with fibrosis and liver diseases, alcoholic. The study is currently recruiting participants at 1 location. People eligible for this study include aged 30 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTtransient 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_TESTEnhanced 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_TESTIndirect serum markers of liver fibrosis

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

DIAGNOSTIC_TESTDirect serum markers of liver fibrosis

Serum markers that reflect liver extracellular matrix turnover and -accumulation

DIAGNOSTIC_TESTLiverTRAIL

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_TESTCytokeratin 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_TESTOmics 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

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NCT03308916

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