Biannual liver cancer screening with ultrasound and AFP for compensated non‑viral cirrhosis in Central Denmark
Introducing HCC Surveillance in the Central Denmark Region
This program will try giving people aged 40–79 with compensated non‑viral cirrhosis ultrasound scans plus AFP blood tests every six months to see if screening lowers deaths from liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 617 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 6 sites (Aarhus, Central Jutland and 5 other locations) |
| Trial ID | NCT07469319 on ClinicalTrials.gov |
What this trial studies
About 600 patients in the Central Denmark Region with compensated non‑viral cirrhosis will be offered HCC surveillance consisting of abdominal ultrasound and an alpha‑fetoprotein (AFP) blood test at 0, 6, and 12 months. Anyone with a positive screen on ultrasound or AFP will be referred for standard diagnostic work‑up, typically beginning with CT. There is no individual randomization; instead HCC‑related mortality in the screened region will be compared with the other four Danish regions using national registry data. The program aims to determine whether organized biannual surveillance leads to earlier detection and fewer deaths from HCC in this patient group.
Who should consider this trial
Good fit: Adults aged 40–79 with compensated non‑viral cirrhosis (no recent variceal bleeding, uncontrolled ascites, or overt hepatic encephalopathy, Child‑Pugh ≤ 8), expected life expectancy ≥1 year, not currently in HCC follow‑up, and residing in Central Denmark are ideal candidates.
Not a fit: Patients with decompensated cirrhosis, chronic hepatitis B or C, limited life expectancy, existing HCC or current HCC follow‑up, or those living outside the Central Denmark Region are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, earlier detection could increase the number of patients eligible for curative treatment and reduce deaths from hepatocellular carcinoma.
How similar studies have performed: Ultrasound with or without AFP has been shown to detect HCC earlier in viral cirrhosis and is guideline‑recommended, but randomized evidence that surveillance reduces mortality in non‑viral cirrhosis is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Aarhus, Central Jutland and 5 other locations
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (Recruiting)
- Regional Hospital Gødstrup — Herning, Central Jutland, Denmark (Recruiting)
- Horsens Regional Hospital — Horsens, Central Jutland, Denmark (Recruiting)
- Randers Regional Hospital — Randers, Central Jutland, Denmark (Recruiting)
- Silkeborg Regional Hospital — Silkeborg, Central Jutland, Denmark (Recruiting)
- Viborg Regional Hospital — Viborg, Central Jutland, Denmark (Recruiting)
Study contacts
- Study coordinator: Peter Jepsen, Professor, MD, PhD
- Email: pj@clin.au.dk
- Phone: +45 29314466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.