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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

NCT07469319 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2026-03-13

No results posted yet for this study

Summary

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

  • Hepatocellular Carcinoma (HCC)
  • Cirrhosis

Interventions

DIAGNOSTIC_TEST

Ultrasound of the liver and blood sample for alpha-fetoprotein

Ultrasound of the liver without Doppler or contrast. Alpha-fetoprotein ≥20 \* 10\^3 IE/l, doubling since last measurement or two consecutive increasing measurements.

Sponsors & Collaborators

  • Gødstrup Hospital

    collaborator OTHER

  • Regionshospitalet Horsens

    collaborator OTHER

  • Randers Regional Hospital

    collaborator OTHER

  • Viborg Regional Hospital

    collaborator OTHER

  • Regionshospitalet Silkeborg

    collaborator OTHER

  • Aarhus University Hospital Skejby

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469319 on ClinicalTrials.gov