Actively Recruiting

Phase Not Applicable
Age: 40Years - 79Years
All Genders
ID07469319

Biannual Screening for Hepatocellular Carcinoma Using Ultrasound and Alpha-Fetoprotein to Reduce Mortality in Patients With Compensated Non-Viral Cirrhosis in the Central Denmark Region

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

617

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

G

Gødstrup Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether repeated screening every six months for hepatocellular carcinoma (HCC), a type of liver cancer, can reduce deaths related to HCC by detecting the cancer earlier. This study focuses on patients with compensated non-viral cirrhosis living in the Central Denmark Region. It compares HCC-related deaths in this region, where screening is offered, to other Danish regions where it is not. The screening involves two tests: an ultrasound of the liver and a blood test measuring alpha-fetoprotein. Patients who test positive on either test will be offered the usual follow-up for HCC, typically starting with a CT scan. The study offers three screening rounds at baseline, six months, and twelve months. There is no individual randomization; instead, outcomes in the screened group will be compared with those in unscreened populations in other regions. Participants will be monitored through registry data for up to 30 months to assess HCC-related mortality, HCC incidence, and overall mortality. Researchers will also track the use of diagnostic tests and conduct sensitivity analyses on HCC-related deaths. The total participant involvement includes three screenings over one year and follow-up via health records until the study ends or death occurs.

CONDITIONS

Brief 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...

  • Diagnosis of 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 of 8 or less
  • Age between 40 and 79 years
  • Expected remaining life expectancy of at least 1 year
  • Not currently in follow-up after treatment for hepatocellular carcinoma
  • No clinical suspicion of hepatocellular carcinoma
Not Eligible

You will not qualify if you...

  • None specified

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Approximately 12 months

Participants undergo biannual screening for hepatocellular carcinoma using abdominal ultrasound and alpha-fetoprotein testing to detect liver cancer early.

3 visits every 6 months

Long-term Monitoring

Duration - Up to 30 months from first screening

Participants are observed over time to track hepatocellular carcinoma-related and all-cause mortality, as well as incidence of liver cancer.

Visits as per routine care and registry data follow-up

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

M

Morten Hallengreen, PhD student

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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