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

NARecruitingINTERVENTIONAL
Enrollment

6,500

Participants

Timeline

Start Date

October 6, 2017

Primary Completion Date

December 30, 2025

Study Completion Date

October 30, 2035

Conditions
Liver Diseases, AlcoholicFibrosis
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

Trial Locations (1)

5000

RECRUITING

Department of Gastroenterology and Hepatology, Odense University Hospital, Odense

Sponsors
All Listed Sponsors
collaborator

Horizon 2020 - European Commission

OTHER

collaborator

Novo Nordisk A/S

INDUSTRY

collaborator

University of Southern Denmark

OTHER

collaborator

Esbjerg University Hospital of South-West Jutland

UNKNOWN

collaborator

Odense Municipality Alcohol Rehabilitation Unit

UNKNOWN

collaborator

Svendborg Municipality Alcohol Rehabilitation Unit

UNKNOWN

collaborator

University of Copenhagen

OTHER

collaborator

University of Oslo

OTHER

collaborator

Nordic Bioscience A/S

INDUSTRY

collaborator

VLV Bio, Peviva AB

UNKNOWN

collaborator

Manatee APS

UNKNOWN

collaborator

Siemens Healthcare A/S

INDUSTRY

collaborator

Steno Diabetes Center Copenhagen

OTHER

collaborator

Biomedical Research Foundation, Academy of Athens

OTHER

collaborator

European Molecular Biology Laboratory, EMBL, University of Heidelberg

UNKNOWN

lead

Maja Thiele

OTHER

NCT03308916 - Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers | Biotech Hunter | Biotech Hunter