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

Sponsor
D'Or Institute for Research and Education
Study ID
NCT07764835
Status
Not Yet Recruiting

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Conditions

  • Advanced Liver Fibrosis
  • Chronic Hepatitis B
  • Hepatocellular Carcinoma
  • Liver Cirrhosis
  • Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: At-Risk Patients Under Structured HCC Surveillance
    Adult participants at increased risk of hepatocellular carcinoma, including patients with cirrhosis, chronic hepatitis B, advanced fibrosis, or metabolic dysfunction-associated steatotic liver disease, enrolled in a structured surveillance program consisting of semiannual ultrasound using US LI-RADS and alpha-fetoprotein assessment as part of routine clinical care.

Primary Outcome Measure

Annual Incidence Rate of Hepatocellular Carcinoma [ Time Frame: Up to 36 months ]

Central Contacts

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