Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound of the liver and blood sample for alpha-fetoprotein | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein
- interventionNames
- Diagnostic Test: Ultrasound of the liver and blood sample for alpha-fetoprotein
- type
- NO_INTERVENTION
- label
- Assigned to standard of care
- description
- 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.
Primary outcomes (1)
- measure
- HCC-related mortality
- timeFrame
- From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months
- description
- HCC recorded as the underlying cause of death in the Danish Cause of Death Registry.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available