Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Liver Fibrosis | — | UNRESOLVED | — |
| Chronic Hepatitis B | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Metabolic Dysfunction-Associated Steatotic Liver Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- At-Risk Patients Under Structured HCC Surveillance
- description
- 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 outcomes (1)
- measure
- Annual Incidence Rate of Hepatocellular Carcinoma
- timeFrame
- Up to 36 months
- description
- Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program
Secondary outcomes (1)
- measure
- Early-Stage HCC Detection Rate
- timeFrame
- Up to 36 months
- description
- Proportion of hepatocellular carcinoma cases diagnosed at BCLC stage 0 or A.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDFonseca LG, Chen ATC, de Oliveira IS, Chagas AL, Kruger JAP, Carrilho FJ. Brazilian Landscape of Hepatocellular Carcinoma. JCO Glob Oncol. 2023 Jun;9:e2200416. doi: 10.1200/GO.22.00416. PMID 37348031
- BACKGROUNDEuropean Association for the Study of the Liver. EASL Clinical Practice Guidelines on the management of hepatocellular carcinoma. J Hepatol. 2025 Feb;82(2):315-374. doi: 10.1016/j.jhep.2024.08.028. Epub 2024 Dec 17. PMID 39690085
- BACKGROUNDSingal AG, Llovet JM, Yarchoan M, Mehta N, Heimbach JK, Dawson LA, Jou JH, Kulik LM, Agopian VG, Marrero JA, Mendiratta-Lala M, Brown DB, Rilling WS, Goyal L, Wei AC, Taddei TH. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology. 2023 Dec 1;78(6):1922-1965. doi: 10.1097/HEP.0000000000000466. Epub 2023 May 22. No abstract available. PMID 37199193
- BACKGROUNDSingal AG, Zhang E, Narasimman M, Rich NE, Waljee AK, Hoshida Y, Yang JD, Reig M, Cabibbo G, Nahon P, Parikh ND, Marrero JA. HCC surveillance improves early detection, curative treatment receipt, and survival in patients with cirrhosis: A meta-analysis. J Hepatol. 2022 Jul;77(1):128-139. doi: 10.1016/j.jhep.2022.01.023. Epub 2022 Feb 6. PMID 35139400