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NCT Number: NCT07469319

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

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cirrhosis Digestive System Diseases Digestive System Neoplasms Fibrosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Central Jutland, Denmark

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About this study

Primary liver cancer is the sixth most common cancer and the third leading cause of cancer-related death. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and often develops in patients with chronic liver disease (cirrhosis), who have a substantially increased risk of HCC.

Because of this high risk, repeated screening for HCC, commonly referred to as HCC surveillance, is recommended by all major international liver societies. The hope is to identify HCC while curative treatment is still possible. In Denmark, HCC surveillance is only recommended for patients with cirrhosis caused by chronic viral hepatitis. Currently, it is not recommended to other patients with cirrhosis due to these patients' low risk of HCC and the lack of randomized studies to determine the efficacy of HCC surveillance as a means to reduce HCC-related or all-cause mortality.

On the study HCC surveillance is introduced for patients with compensated non-viral cirrhosis in the Central Denmark Region, one of Denmark's five administrative regions. Screening will consist of biannual abdominal ultrasound combined with alpha-fetoprotein (AFP) testing. Patients who screen positive will be offered standard work-up for HCC. 600 patients are expected to be enrolled and they will be offered three rounds of screening at 0, 6 months, and 12 months, i.e., there is no individual-level randomization in this study. Instead, national registry data will be used to compare HCC-related mortality (the primary outcome) and HCC incidence and other secondary outcomes between the Central Denmark Region and the other four Danish regions where HCC surveillance is not offered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ≤ 8
  • Age 40-79 years
  • Expected remaining life expectancy ≥ 1 year
  • Not already in follow-up after treatment for HCC
  • No clinical suspicion of HCC

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

  1. 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

    HCC recorded as the underlying cause of death in the Danish Cause of Death Registry.

Secondary outcomes

  1. HCC incidence

    Time frame: From date of inclusion until diagnosis of hepatocellular carcinoma or end of follow-up, assessed up to 30 months.

    Incidence of HCC determined a diagnosis code for HCC (ICD-10: C22.0) recorded in the Danish Cancer Register and/or as a primary diagnosis code in the Danish National Patient Register.

  2. All-cause mortality

    Time frame: From date of first screening to first occurrence of death from any cause assessed up to 30 months.

    Survival time based on information from the Danish Central Office of Civil Registration.

  3. Use of diagnostic tests

    Time frame: From date of inclusion to first occurrence of death from any cause or diagnosis of hepatocellular carcinoma, assessed up to 30 months.

    This includes:

    Alpha-fetoprotein Ultrasound of the liver CT of the liver, including 3-phase or 4-phase liver CT MR of the liver Liver biopsy for HCC

  4. HCC-related mortality (sensitivity analysis)

    Time frame: From date of first screening to first occurrence of death from hepatocellular carcinoma, assessed up to 30 months.

    HCC recorded anywhere on the death certificate (immediate, underlying, or contributory cause) in the Danish Cause of Death Registry.

Study contacts

Contact information is provided by the study sponsor or research team.

Morten Hallengreen, PhD student

CONTACT

[email protected]

+45 60154398

Peter Jepsen, Professor, MD, PhD

CONTACT

[email protected]

+45 29314466

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital Skejby
  • Gødstrup Hospital
  • Randers Regional Hospital
  • Regionshospitalet Horsens
  • Regionshospitalet Silkeborg
  • Viborg Regional Hospital

Registry information

Official study title

Introducing HCC Surveillance in the Central Denmark Region

Acronym: BISHOP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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