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Introducing HCC Surveillance in the Central Denmark Region

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Regional Hospital Gødstrup
RECRUITING
Herning
Horsens Regional Hospital
RECRUITING
Horsens
Randers Regional Hospital
RECRUITING
Randers
Silkeborg Regional Hospital
RECRUITING
Silkeborg
Viborg Regional Hospital
RECRUITING
Viborg
Contact Information
Primary
Peter Jepsen, Professor, MD, PhD
pj@clin.au.dk
+45 29314466
Backup
Morten Hallengreen, PhD student
mohall@clin.au.dk
+45 60154398
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 617
Treatments
Experimental: Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein
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.
Related Therapeutic Areas
Sponsors
Collaborators: Regionshospitalet Horsens, Viborg Regional Hospital, Gødstrup Hospital, Randers Regional Hospital, Regionshospitalet Silkeborg, Aarhus University Hospital Skejby
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov