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 (BISHOP)

March 12, 2026 updated by: Peter Jepsen, University of Aarhus

Introducing HCC Surveillance in the Central Denmark Region

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

617

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peter Jepsen, Professor, MD, PhD
  • Phone Number: +45 29314466
  • Email: pj@clin.au.dk

Study Contact Backup

  • Name: Morten Hallengreen, PhD student
  • Phone Number: +45 60154398
  • Email: mohall@clin.au.dk

Study Locations

  • Denmark
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Morten Hallengreen, MD. and PhD student
          • Phone Number: +4560154398
          • Email: mohall@clin.au.dk
        • Contact:
          • Peter Jepsen, MD, Clinical Professor
          • Phone Number: +4529314466
          • Email: pj@clin.au.dk
      • Herning, Central Jutland, Denmark, 7400
      • Horsens, Central Jutland, Denmark, 8700
        • Recruiting
        • Horsens Regional Hospital
        • Contact:
      • Randers, Central Jutland, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:
          • Asser M Oppfeldt, MD
          • Phone Number: +4561681208
          • Email: asseoppf@rm.dk
      • Silkeborg, Central Jutland, Denmark, 8600
        • Recruiting
        • Silkeborg Regional Hospital
        • Contact:
      • Viborg, Central Jutland, Denmark, 8800
        • Recruiting
        • Viborg Regional Hospital
        • Contact:
          • Michael Sørensen, MD. PhD
          • Phone Number: +4525379750
          • Email: michsoer@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein
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.
No Intervention: Assigned to standard of care
These patients are not followed within the study. Instead, patients in the target population from other regions in Denmark-who are comparable to those receiving the intervention-will serve as the comparison group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of inclusion until diagnosis of hepatocellular carcinoma or end of follow-up, assessed up to 30 months.
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.
From date of first screening to first occurrence of death from any cause assessed up to 30 months.
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
From date of inclusion to first occurrence of death from any cause or diagnosis of hepatocellular carcinoma, assessed up to 30 months.
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.
From date of first screening to first occurrence of death from hepatocellular carcinoma, assessed up to 30 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-55-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Our study design implies that we have no contact with the population offered the standard-of-care, who will be identified through the Danish healthcare registers. Moreover, all outcome information will be collected through the Danish healthcare registers. We will only be allowed access to these healthcare registers through a remote server in a Trusted Research Environment (TRE). Danish law prohibits us from downloading, let alone sharing, data from the TRE.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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