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

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.

Conditions

• Liver Diseases, Alcoholic
• Fibrosis

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

Sponsors & Collaborators

• Horizon 2020 - European Commission

  collaborator OTHER

• Novo Nordisk A/S

  collaborator INDUSTRY

• University of Southern Denmark

  collaborator OTHER

• Esbjerg University Hospital of South-West Jutland

  collaborator UNKNOWN

• Odense Municipality Alcohol Rehabilitation Unit

  collaborator UNKNOWN

• Svendborg Municipality Alcohol Rehabilitation Unit

  collaborator UNKNOWN

• University of Copenhagen

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Nordic Bioscience A/S

  collaborator INDUSTRY

• VLV Bio, Peviva AB

  collaborator UNKNOWN

• Manatee APS

  collaborator UNKNOWN

• Siemens Healthcare A/S

  collaborator INDUSTRY

• Steno Diabetes Center Copenhagen

  collaborator OTHER

• Biomedical Research Foundation, Academy of Athens

  collaborator OTHER

• European Molecular Biology Laboratory, EMBL, University of Heidelberg

  collaborator UNKNOWN

• Maja Thiele

  lead OTHER

Principal Investigators

• Maja Thiele, MD, PhD, Professor · Department of Gastroenterology and Hepatology, Odense University Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-06

Primary Completion

2025-12-30

Completion

2035-10-30

Countries

• Denmark

Study Locations