Actively Recruiting

Phase Not Applicable
Age: 40Years - 79Years
All Genders
NCT07469319

Biannual Screening for HCC Offered to Patients With Cirrhosis. Introducing Surveillance for Hepatocellular Carcinoma (HCC) in the Central Denmark Region Using Ultrasound and Alpha-Fetoprotein to Reduce HCC-Related Mortality in Patients With Compensated Non-Viral Cirrhosis

Led by University of Aarhus · Updated on 2026-03-13

617

Participants Needed

6

Research Sites

130 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

G

Gødstrup Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to investigate whether repeated 6-monthly screening for hepatocellular carcinoma (HCC) - called "HCC surveillance" - offered to selected patients with chronic liver disease can reduce HCC-related mortality by facilitating earlier detection of HCC. The screening procedure consists of two tests: an ultrasound examination of the liver and a blood sample to measure alpha-fetoprotein. Patients who screen positive on either examination will be offered standard work-up for HCC, typically beginning with a CT-scan. In the study HCC surveillance will be offered to all patients with compensated non-viral cirrhosis residing in the Central Denmark Region, one of five administrative regions of Denmark. The study aims to determine the efficacy of HCC surveillance in reducing HCC-related mortality by comparing HCC-related mortality between the Central Denmark Region and the other four Danish regions, where HCC surveillance is not offered.

CONDITIONS

Official Title

Biannual Screening for HCC Offered to Patients With Cirrhosis. Introducing Surveillance for Hepatocellular Carcinoma (HCC) in the Central Denmark Region Using Ultrasound and Alpha-Fetoprotein to Reduce HCC-Related Mortality in Patients With Compensated Non-Viral Cirrhosis

Who Can Participate

Age: 40Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cirrhosis

  • No history of chronic hepatitis B or C

  • Compensated cirrhosis defined as:

    • No recent variceal bleeding, no uncontrolled ascites, no clinically apparent hepatic encephalopathy, and Child-Pugh score ≤ 8
  • Age 40-79 years

  • Expected remaining life expectancy ≥ 1 year

  • Not already in follow-up after treatment for HCC

  • No clinical suspicion of HCC

Not Eligible

You will not qualify if you...

-

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Trial Site Locations

Total: 6 locations

1

Aarhus University Hospital

Aarhus, Central Jutland, Denmark, 8200

Actively Recruiting

2

Regional Hospital Gødstrup

Herning, Central Jutland, Denmark, 7400

Actively Recruiting

3

Horsens Regional Hospital

Horsens, Central Jutland, Denmark, 8700

Actively Recruiting

4

Randers Regional Hospital

Randers, Central Jutland, Denmark, 8930

Actively Recruiting

5

Silkeborg Regional Hospital

Silkeborg, Central Jutland, Denmark, 8600

Actively Recruiting

6

Viborg Regional Hospital

Viborg, Central Jutland, Denmark, 8800

Actively Recruiting

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Research Team

P

Peter Jepsen, Professor, MD, PhD

CONTACT

M

Morten Hallengreen, PhD student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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