Hepatocellular Carcinoma (HCC)BISHOPNCT07469319
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
A study testing Ultrasound of the liver and blood sample for alpha-fetoprotein in people with Hepatocellular Carcinoma (HCC) and Cirrhosis, run by University of Aarhus at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Cirrhosis
- What is being tested?
- Ultrasound of the liver and blood sample for alpha-fetoprotein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 617 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 Jan 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Morten Hallengreen, MD. and PhD student, +4560154398, mohall@clin.au.dk
Peter Jepsen, MD, Clinical Professor, +4529314466, pj@clin.au.dk
- Recruiting
Regional Hospital Gødstrup
Herning, Central Jutland, 7400
Maria J Alexandraki, MD, maria.alex@midt.rm.dk
- Recruiting
Horsens Regional Hospital
Horsens, Central Jutland, 8700
Lisbet Grønbæk, MD. PhD, +4578426966, Lisbet.Groenbaek@auh.rm.dk
- Recruiting
Randers Regional Hospital
Randers, Central Jutland, 8930
Asser M Oppfeldt, MD, +4561681208, asseoppf@rm.dk
- Recruiting
Silkeborg Regional Hospital
Silkeborg, Central Jutland, 8600
Charlotte H Holmboe, MD, CHARHL@rm.dk
- Recruiting
Viborg Regional Hospital
Viborg, Central Jutland, 8800
Michael Sørensen, MD. PhD, +4525379750, michsoer@rm.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma (HCC), Cirrhosis
- Being tested
- Ultrasound of the liver and blood sample for alpha-fetoprotein
- Keywords
- Screening for HCC in compensated non-viral cirrhosis, HCC surveillance, HCC screening
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the liver and blood sample for alpha-fetoproteinDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein | Experimental | Not described Receives: Diagnostic Test: Ultrasound of the liver and blood sample for alpha-fetoprotein |
| Assigned to standard of care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
HCC-related mortality
HCC recorded as the underlying cause of death in the Danish Cause of Death Registry.
Measured: From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months
Secondary outcomes (4)
HCC incidence
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.
Measured: From date of inclusion until diagnosis of hepatocellular carcinoma or end of follow-up, assessed up to 30 months.
All-cause mortality
Survival time based on information from the Danish Central Office of Civil Registration.
Measured: From date of first screening to first occurrence of death from any cause assessed up to 30 months.
Use of diagnostic tests
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
Measured: 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)
HCC recorded anywhere on the death certificate (immediate, underlying, or contributory cause) in the Danish Cause of Death Registry.
Measured: From date of first screening to first occurrence of death from hepatocellular carcinoma, assessed up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled in the Central Denmark Region will receive the intervention. They will then be compared to patients from the other Danish Regions who receive the standard of care.
- Masking
- None (open label)
- Enrolment
- 617 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Gødstrup Hospital, Regionshospitalet Horsens, Randers Regional Hospital, Viborg Regional Hospital, Regionshospitalet Silkeborg, Aarhus University Hospital Skejby
- Responsible party
- Principal investigator, Peter Jepsen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469319
- Sponsor's protocol ID
- 1-10-72-55-25
- Acronym
- BISHOP
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing HCC Surveillance in the Central Denmark Region
- ClinicalTrials.gov ID
- NCT07469319
- Acronym / sponsor ID
- BISHOP / 1-10-72-55-25
- Conditions
- Hepatocellular Carcinoma (HCC), Cirrhosis
- Keywords
- Screening for HCC in compensated non-viral cirrhosis, HCC surveillance, HCC screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 617 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Gødstrup Hospital, Regionshospitalet Horsens, Randers Regional Hospital, Viborg Regional Hospital, Regionshospitalet Silkeborg, Aarhus University Hospital Skejby
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients enrolled in the Central Denmark Region will receive the intervention. They will then be compared to patients from the other Danish Regions who receive the standard of care.
| Arm | Type | Receives |
|---|---|---|
| Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein | Experimental | Diagnostic Test: Ultrasound of the liver and blood sample for alpha-fetoprotein |
| Assigned to standard of care | No intervention | –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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cirrhosis
- No history of chronic hepatitis B or C
- Compensated cirrhosis defined as:
- Age 40-79 years
- Expected remaining life expectancy ≥ 1 year
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound of the liver and blood sample for alpha-fetoproteinUltrasound of the liver without Doppler or contrast. Alpha-fetoprotein ≥20 * 10^3 IE/l, doubling since last measurement or two consecutive increasing measurements. | Diagnostic test | Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein |
Primary outcome
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.
4 secondary outcomes
HCC incidence
Time frame: 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Hepatocellular Carcinoma (HCC)
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the liver and blood sample for alpha-fetoprotein in people with Hepatocellular Carcinoma (HCC) and Cirrhosis, run by University of Aarhus at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Jepsen, Professor, MD, PhD (+45 29314466, pj@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.