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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative HBeAg Testing | Diagnostic Test | Quantitative HBeAg Testing in Population-Based Primary Screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of HCC | The number of newly diagnosed HCC cases divided by total person-years at risk during follow-up for each screening strategy. | 3 years |
| Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.) | Sensitivity, specificity, positive predictive value(PPV) and area under the ROC curve (AUC) will be calculated to evaluate the discrimination of each model. | 3 years |
| Risk stratification accuracy | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Screening positivity and referral rate | Proportion of participants identified as medium/high-risk and referred for further diagnostic imaging (e.g.,pathology/CT/MRI). | 3 years |
| Stage distribution of HCC cases identified by different screening strategies |
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Inclusion Criteria:
Exclusion Criteria:
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Local household-registered residents aged ≥35 years, HBsAg-positive, with no prior diagnosis of HCC, residing in Zhongshan City.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingfang Ji, MD | Contact | 86-0760-89880417 | jmftbh@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan People's Hospital | Recruiting | Zhongshan | Guangdong | 528403 | China |
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Blood
| Measurement Indicators Required for Risk Scoring in HCC Screening Strategies | Biological | REACH-B: Age, Sex, HBeAg status, ALT levels, and HBV DNA load; AGED: Age, Sex, HBeAg status, HBV DNA load; aMAP: Age, Sex, Albumin, Total Bilirubin, Platelet Count; aMAP 3.0: Age, Sex, Albumin, Total Bilirubin, Platelet Count, AFP and PIVKA-II. |
|
| Follow-Up Monitoring Parameters | Biological | AFP, Liver Ultrasound |
|
| 3 years |
| Early detection rate of HCC cases identified by different screening strategies | 3 years |
| Number Needed to Screen (NNS) | Number of individuals needed to be screened to prevent one case of HCC. | 3 years |
| Incremental Cost-Effectiveness Ratio (ICER) | The additional cost required to gain one extra QALY or to prevent one HCC case using a given model, compared with baseline strategy. | 3 years |
| Time-dependent AUC or C-index | Model discrimination assessed at different time points using time-dependent ROC curves and concordance index (C-index). | 3 years |
| Model performance in subgroups | Subgroup analyses to compare predictive performance of each model in different populations (e.g., by sex, age, ALT level, HBV DNA level). | 3 years |
| Overall survival (OS) | Indicates whether the participant was alive at the end of follow-up and their survival duration. | 3 years |
| Screening adherence | The proportion of participants who completed biannual AFP and ultrasound screenings as scheduled during follow-up. | 3 years |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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