About this trial
This prospective multicenter observational study evaluates the performance of a structured hepatocellular carcinoma (HCC) surveillance program in patients at increased risk of developing liver cancer. Participants will undergo routine surveillance with semiannual abdominal ultrasound reported using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS) and serum alpha-fetoprotein (AFP) testing as part of standard clinical care. The study aims to assess HCC detection rates, stage at diagnosis, detection of other hepatic malignancies, and the time intervals between detection, diagnosis, and treatment in a real-world setting. Approximately 300 participants will be enrolled and followed for up to 36 months.
Eligibility criteria
Qualifiers
Written informed consent.
Age 18 years or older.
Liver cirrhosis of any etiology.
Chronic hepatitis B with moderate or high risk of HCC according to PAGE-B criteria.
Disqualifiers
Known hepatocellular carcinoma at enrollment.
Previous diagnosis of hepatocellular carcinoma.
Metastatic liver disease.
Other malignant liver tumors present at enrollment.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
D'Or Institute for Research and Education
Lead sponsor
AstraZeneca
Collaborator