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Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)

Not Yet RecruitingN/A

Sponsor: D'Or Institute for Research and Education

Conditions: Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis B, Metabolic Dysfunction-Associated Steatotic Liver Disease, Advanced Liver Fibrosis

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* Non-cirrhotic chronic liver disease with increased risk for HCC, including fibrosis stage 3 or higher or metabolic dysfunction-associated steatotic liver disease (MASLD) with one or more risk factors for HCC.
* Followed at hepatology clinics within the Rede D'Or health network.
* Eligible for routine HCC surveillance with ultrasound and alpha-fetoprotein according to standard clinical practice.

Exclusion Criteria:

* Known hepatocellular carcinoma at enrollment.
* Previous diagnosis of hepatocellular carcinoma.
* Metastatic liver disease.
* Other malignant liver tumors present at enrollment.
* Clinical condition preventing routine surveillance follow-up.
* Inability to provide informed consent.