Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Risk stratification accuracy
研究概览
简要总结
Based on the preliminary retrospective validation of the efficacy of five HCC screening strategies(including conventional AFP combined with ultrasound-based general screening strategy, REACH-B, AGED, aMAPand aMAP 3.0 risk score) in Xiaolan Town, a head-to-head comparison for HCC screening is conducted in Zhongshan City, Guangdong Province. The study is a prospective, single-center, head-to-head trial aiming to enroll 4,500 HBsAg-positive individuals. It adopts a two-phase design of "HBV screening first, followed by HCC surveillance":Phase I: Recruitment of age-eligible populations at study sites for HBsAg screening to establish a high-risk cohort positive for hepatitis B surface antigen.Phase II: Implementation of uniform HCC surveillance (AFP combined with liver ultrasound every six months) for HBsAg-positive individuals, with concurrent application of different risk stratification models to evaluate risk levels and screening efficacy for each participant during follow-up.Furthurmore, based on baseline biological information and follow-up data, the study also aims to explore the development of a more effective risk prediction model for HCC.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the informed consent form.
- •Household registration in Zhongshan City, Guangdong Province.
- •Aged 35 and above.
- •Positive screening result for Hepatitis B surface antigen (HBsAg).
排除标准
- •Previous history of liver cancer or liver transplantation.
- •Pregnant women.
- •Severe comorbidities (e.g., end-stage cardiopulmonary diseases, advanced malignancies).
- •Individuals lacking legal capacity or unable to provide informed consent.
研究组 & 干预措施
HCC Screening Dynamic Cohort
Local household-registered residents aged 35-64 years who are HBsAg-positive and have not been diagnosed with HCC prior to enrollment, residing in the study site communities of Zhongshan City
干预措施: Quantitative HBeAg Testing (Diagnostic Test)
HCC Screening Dynamic Cohort
Local household-registered residents aged 35-64 years who are HBsAg-positive and have not been diagnosed with HCC prior to enrollment, residing in the study site communities of Zhongshan City
干预措施: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies (Biological)
HCC Screening Dynamic Cohort
Local household-registered residents aged 35-64 years who are HBsAg-positive and have not been diagnosed with HCC prior to enrollment, residing in the study site communities of Zhongshan City
干预措施: Follow-Up Monitoring Parameters (Biological)
结局指标
主要结局
Risk stratification accuracy
时间窗: 3 years
Participants will be categorized into different risk strata (high, intermediate, low) by each model, and their observed HCC incidence will be compared to assess stratification accuracy.
Incidence of HCC
时间窗: 3 years
The number of newly diagnosed HCC cases divided by total person-years at risk during follow-up for each screening strategy.
Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.)
时间窗: 3 years
Sensitivity, specificity, positive predictive value(PPV) and area under the ROC curve (AUC) will be calculated to evaluate the discrimination of each model.
次要结局
- Screening positivity and referral rate(3 years)
- Early detection rate of HCC cases identified by different screening strategies(3 years)
- Number Needed to Screen (NNS)(3 years)
- Stage distribution of HCC cases identified by different screening strategies(3 years)
- Incremental Cost-Effectiveness Ratio (ICER)(3 years)
- Time-dependent AUC or C-index(3 years)
- Overall survival (OS)(3 years)
- Model performance in subgroups(3 years)
- Screening adherence(3 years)
研究者
Mingfang Ji
Clinical Professor
Zhongshan People's Hospital, Guangdong, China