NCT07764835Not yet recruiting
Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients (Screening HCC)
Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients Using Semiannual Ultrasound LI-RADS and Alpha-Fetoprotein: A Multicenter Real-World Observational Study
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- D'Or Institute for Research and Education
- NCT number
- NCT07764835
What you commit to
- Study type: Observational
- Planned participants: 300
- From 15 Sept 2026 to the primary completion date, 30 Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of hepatocellular carcinoma.
Other illness
- Metastatic liver disease.
- Other malignant liver tumors present at enrollment.
- Clinical condition preventing routine surveillance follow-up.
Other
- Known hepatocellular carcinoma at enrollment.
- Inability to provide informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.