Health TrialsbyHealthPanel

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

ConditionsLiver Diseases, AlcoholicFibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorMaja Thiele

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 30-75 years (except the general population, which should be aged 40-75)

Informed consent to study investigations

Ability to read and write Danish AND (only at-risk patients)

Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR

Disqualifiers

Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding.

Known concurrent liver disease other than ALD and NAFLD.

Cancer or other debilitating disease with an expected survival of less than 12 months.

Inability to comply with the study protocol.

Trial design

Design model

Single group

Treatments tested in this trial

  • transient elastography

    Diagnostic test

    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

    Diagnostic 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 test

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

  • Direct serum markers of liver fibrosis

    Diagnostic test

    Serum markers that reflect liver extracellular matrix turnover and -accumulation

  • LiverTRAIL

    Diagnostic test

    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

    Diagnostic test

    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

    Diagnostic test

    Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies

Treatment groups

6,500 Participants
are divided into 1 treatment group
Group A: Liver stiffness measurementExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Biopsy-verified advanced fibrosis

Number of patients with biopsy-verified, advanced fibrosis (Kleiner fibrosis score ≥F3) detected by screening

Time frame
5 years
2

Liver-related outcomes

Number of liver-related clinical outcomes during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts). Liver-related outcomes are defined as liver-related death, liver transplant, progression to liver-related complications (ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, jaundice, bleeding from esophagastric varices, hepatocellular carcinoma) or MELD-Na score \>15

Time frame
10 years

Secondary outcomes

1

Liver related outcomes

Number of liver-related clinical outcomes during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts). Liver-related outcomes are defined as liver-related death, liver transplant, progression to liver-related complications (ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, jaundice, bleeding from esophagastric varices, hepatocellular carcinoma) or MELD-Na score \>15

Time frame
10 years
2

Mortality

Overall number of deaths during 10 years of follow up after the first screened patient, compared to a matched, historical control group (The Inter99 study and the Copenhagen and Odense alcohol rehabilitation cohorts).

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maja Thiele

Lead sponsor

Odense University Hospital

Sponsor institution

Horizon 2020 - European Commission

Collaborator

Novo Nordisk A/S

Collaborator

University of Southern Denmark

Collaborator

Esbjerg University Hospital of South-West Jutland

Collaborator

Odense Municipality Alcohol Rehabilitation Unit

Collaborator

Svendborg Municipality Alcohol Rehabilitation Unit

Collaborator

University of Copenhagen

Collaborator

University of Oslo

Collaborator

Nordic Bioscience A/S

Collaborator

VLV Bio, Peviva AB

Collaborator

Manatee APS

Collaborator

Siemens Healthcare A/S

Collaborator

Steno Diabetes Center Copenhagen

Collaborator

Biomedical Research Foundation, Academy of Athens

Collaborator

Heidelberg University

Collaborator

Source ClinicalTrials.gov
Apply now