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

Sponsor
University of Aarhus
Study ID
NCT07469319
Status
Recruiting
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Conditions

  • Cirrhosis
  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
40 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound of the liver and blood sample for alpha-fetoprotein — DIAGNOSTIC_TEST
    Ultrasound of the liver without Doppler or contrast. Alpha-fetoprotein ≥20 \* 10\^3 IE/l, doubling since last measurement or two consecutive increasing measurements.

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
Jan 1, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
617 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein
  • No Intervention: Assigned to standard of care
    These patients are not followed within the study. Instead, patients in the target population from other regions in Denmark-who are comparable to those receiving the intervention-will serve as the comparison group.

Primary Outcome Measure

HCC-related mortality [ Time Frame: From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months ]

Central Contacts

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