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.
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.
Known hepatocellular carcinoma at enrollment.
Previous diagnosis of hepatocellular carcinoma.
Metastatic liver disease.
Other malignant liver tumors present at enrollment.
Adult patients at increased risk for hepatocellular carcinoma, including individuals with liver cirrhosis, chronic hepatitis B, advanced fibrosis, and metabolic dysfunction-associated steatotic liver disease who are receiving routine care within the Rede D'Or healthcare network.
Cohort
Prospective
Not listed
Annual Incidence Rate of Hepatocellular Carcinoma
Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program
Early-Stage HCC Detection Rate
Proportion of hepatocellular carcinoma cases diagnosed at BCLC stage 0 or A.
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D'Or Institute for Research and Education
Lead sponsor
AstraZeneca
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
