Prospective Evaluation of a Locked Risk-Stratified Surveillance Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,523
- 试验地点
- 1
- 主要终点
- Incident Extrahepatic Metastasis (EHM)
研究概览
简要总结
This is a multicenter prospective observational cohort study in adults with hepatocellular carcinoma (HCC) without baseline extrahepatic metastasis who are receiving routine clinical management and follow-up at participating centers. The study evaluates the real-world implementation and clinical utility of a locked machine learning-guided risk stratification strategy for predicting lung and bone metastasis and supporting risk-stratified surveillance. The locked strategy uses prespecified 12-month risk thresholds and linked care pathways and is implemented without retraining or threshold revision. No study-mandated treatment or surveillance assignment is performed; clinical care remains at physician discretion according to local practice. The study assesses model transportability and calibration, implementation outcomes (including completion of prespecified actions, timeliness of action, and treatment activation), clinically actionable detection outcomes, patient-important outcomes, and longer-term survival. Comparative analyses use centre- and calendar-epoch-aligned usual-care episodes as the primary observational comparator.
详细描述
Background and Rationale: Hepatocellular carcinoma (HCC) carries a substantial risk of postoperative or post-treatment recurrence and extrahepatic metastasis, which may affect prognosis and management opportunities. Early identification of patients at increased risk of extrahepatic metastasis may support more appropriate surveillance intensity, earlier multidisciplinary review, and more timely treatment planning.
Study Objectives: This study prospectively evaluates the real-world transportability, calibration, implementation characteristics, and clinical utility of a previously developed and locked machine learning-guided risk stratification strategy for extrahepatic metastasis in HCC, with a focus on lung and bone metastasis.
Study Design: This is a multicenter prospective observational cohort study conducted in routine clinical practice. Participants are enrolled and followed without randomization or study-mandated treatment allocation. The locked strategy includes endpoint-specific lung and bone metastasis risk modules, fixed 12-month risk thresholds, and linked risk-stratified surveillance recommendations. The prospective program includes staged real-world implementation, including an independent new-centre replication phase using the unchanged locked package.
Study Population: Adults with HCC without baseline extrahepatic metastasis at the first eligible risk assessment who are receiving routine care at participating centers.
Study Procedures and Data Collection: Baseline demographics, liver disease etiology, tumor burden and stage, liver reserve and performance status, biomarkers, imaging, treatment intent, follow-up imaging, occurrence and timing of extrahepatic metastasis, downstream management, implementation metrics, and clinical outcomes are collected prospectively from routine care records and study documentation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of hepatocellular carcinoma (HCC) confirmed by histopathology or accepted radiologic criteria per international guidelines.
- •No evidence of extrahepatic metastasis at baseline evaluation.
- •Receiving standard-of-care management with planned longitudinal follow-up in routine clinical practice.
- •Availability of baseline clinical and imaging data required for risk assessment using the pre-specified machine learning model.
- •Ability to provide written informed consent, or inclusion under ethics committee-approved procedures.
排除标准
- •Confirmed extrahepatic metastasis at enrollment (baseline).
- •History of other active malignancy within the past 5 years, except adequately treated non-melanoma skin cancer or in situ carcinoma.
- •Incomplete baseline clinical information that precludes model-based risk assessment.
- •Expected survival < 3 months due to severe comorbidities.
- •Participation in an interventional clinical trial that may substantially alter follow-up strategy or metastasis assessment.
研究组 & 干预措施
Prospective Observational Cohort
Adults with hepatocellular carcinoma without baseline extrahepatic metastasis enrolled in a prospective observational cohort to evaluate a locked machine learning-guided risk stratification strategy for predicting lung and bone metastasis and supporting risk-stratified surveillance in routine practice. No experimental interventions are assigned, and clinical management remains at physician discretion.
干预措施: Machine Learning-Based Risk Assessment (Other)
结局指标
主要结局
Incident Extrahepatic Metastasis (EHM)
时间窗: Up to 36 months
New extrahepatic metastatic disease detected after baseline and confirmed by imaging (CT/MRI/PET-CT) and/or histopathology, documented in the medical record.
次要结局
- Completion of a Prespecified Action Within 60 Days(Completion of the prespecified risk-stratified surveillance or management action within 60 days after the first eligible locked risk assessment.)
- Overall survival (OS)(Up to 36 months)