RecruitingNot ApplicableNCT07469319

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

Introducing HCC Surveillance in the Central Denmark Region


Sponsor

University of Aarhus

Enrollment

617 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a twice-yearly screening program — using ultrasound scans and a blood test (alpha-fetoprotein) — to detect liver cancer (hepatocellular carcinoma, or HCC) early in patients with liver cirrhosis (scarring of the liver) who do not have viral hepatitis. **You may be eligible if...** - You have been diagnosed with liver cirrhosis - You do NOT have a history of chronic hepatitis B or C - Your cirrhosis is compensated (no recent major complications like bleeding, uncontrolled fluid buildup, or confusion from liver failure; Child-Pugh score of 8 or less) - You are between 40 and 79 years old - Your expected life expectancy is at least 1 year - You have not previously been treated for liver cancer - There is no current suspicion of liver cancer **You may NOT be eligible if...** - You have cirrhosis caused by hepatitis B or C - You are already receiving follow-up care after liver cancer treatment - You are already suspected of having liver cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUltrasound 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.


Locations(6)

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Regional Hospital Gødstrup

Herning, Central Jutland, Denmark

Horsens Regional Hospital

Horsens, Central Jutland, Denmark

Randers Regional Hospital

Randers, Central Jutland, Denmark

Silkeborg Regional Hospital

Silkeborg, Central Jutland, Denmark

Viborg Regional Hospital

Viborg, Central Jutland, Denmark

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NCT07469319


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