Prospective Evaluation of Hepatocellular Carcinoma Surveillance in At-Risk Patients Using Semiannual Ultrasound LI-RADS and Alpha-Fetoprotein: A Multicenter Real-World Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Annual Incidence Rate of Hepatocellular Carcinoma
研究概览
简要总结
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.
详细描述
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and remains a leading cause of cancer-related mortality worldwide. Early detection through surveillance is associated with improved access to curative therapies and better survival outcomes. Despite international guideline recommendations, implementation of surveillance programs remains heterogeneous in routine clinical practice, and limited real-world evidence is available regarding the effectiveness of structured HCC surveillance pathways in Brazil.
This prospective multicenter observational study is designed to evaluate the performance of a structured HCC surveillance program implemented within the Rede D'Or healthcare network. The program combines standardized abdominal ultrasound reporting using the Ultrasound Liver Imaging Reporting and Data System (US LI-RADS), regular alpha-fetoprotein (AFP) assessment, dedicated training of healthcare professionals, and predefined referral pathways for diagnostic evaluation and clinical management.
The study aims to generate real-world evidence regarding the effectiveness of standardized surveillance strategies in populations at increased risk for HCC. In addition to evaluating HCC detection, the study will assess the clinical characteristics and staging patterns of diagnosed tumors, detection of other malignant liver lesions, and the efficiency of the diagnostic and treatment pathway. Special attention will be given to patients who do not fully meet traditional surveillance criteria but may still present clinically relevant risk for HCC, including individuals with advanced fibrosis and metabolic dysfunction-associated steatotic liver disease (MASLD).
No experimental interventions will be administered as part of this protocol. All surveillance procedures, diagnostic investigations, and treatment decisions will be performed according to routine clinical practice and the judgment of treating physicians. Data generated during routine care will be collected prospectively and analyzed to better understand the effectiveness of structured surveillance programs in real-world clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Annual Incidence Rate of Hepatocellular Carcinoma
时间窗: Up to 36 months
Incidence of newly diagnosed hepatocellular carcinoma among participants enrolled in the structured surveillance program
次要结局
- Early-Stage HCC Detection Rate(Up to 36 months)