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
Introducing HCC Surveillance in the Central Denmark Region
1 other identifier
interventional
617
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
March 13, 2026
March 1, 2026
2.5 years
January 5, 2026
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HCC-related mortality
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 Outcomes (4)
HCC incidence
From date of inclusion until diagnosis of hepatocellular carcinoma or end of follow-up, assessed up to 30 months.
All-cause mortality
From date of first screening to first occurrence of death from any cause assessed up to 30 months.
Use of diagnostic tests
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)
From date of first screening to first occurrence of death from hepatocellular carcinoma, assessed up to 30 months.
Study Arms (2)
Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein
EXPERIMENTALAssigned to standard of care
NO INTERVENTIONThese 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.
Interventions
Ultrasound of the liver without Doppler or contrast. Alpha-fetoprotein ≥20 \* 10\^3 IE/l, doubling since last measurement or two consecutive increasing measurements.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Gødstrup Hospitalcollaborator
- Regionshospitalet Horsenscollaborator
- Randers Regional Hospitalcollaborator
- Viborg Regional Hospitalcollaborator
- Regionshospitalet Silkeborgcollaborator
- Aarhus University Hospital Skejbycollaborator
Study Sites (6)
Aarhus University Hospital
Aarhus, Central Jutland, 8200, Denmark
Regional Hospital Gødstrup
Herning, Central Jutland, 7400, Denmark
Horsens Regional Hospital
Horsens, Central Jutland, 8700, Denmark
Randers Regional Hospital
Randers, Central Jutland, 8930, Denmark
Silkeborg Regional Hospital
Silkeborg, Central Jutland, 8600, Denmark
Viborg Regional Hospital
Viborg, Central Jutland, 8800, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Hepatologist, Professor, MD
Study Record Dates
First Submitted
January 5, 2026
First Posted
March 13, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.