Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- None specified
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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