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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorD'Or Institute for Research and Education

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

300 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators