Hepatocellular Cancer (HCC)
Conditions
Keywords
Screening, Hepatocellular Cancer, aMAP
Brief summary
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.
Interventions
DIAGNOSTIC_TESTQuantitative HBeAg Testing
Quantitative HBeAg Testing in Population-Based Primary Screening
BIOLOGICALMeasurement Indicators Required for Risk Scoring in HCC Screening Strategies
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.
BIOLOGICALFollow-Up Monitoring Parameters
AFP, Liver Ultrasound
Sponsors
Zhongshan People's Hospital, Guangdong, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of HCC | 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.) | 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. |
| Risk stratification accuracy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number Needed to Screen (NNS) | 3 years | Number of individuals needed to be screened to prevent one case of HCC. |
| Incremental Cost-Effectiveness Ratio (ICER) | 3 years | The additional cost required to gain one extra QALY or to prevent one HCC case using a given model, compared with baseline strategy. |
| Time-dependent AUC or C-index | 3 years | Model discrimination assessed at different time points using time-dependent ROC curves and concordance index (C-index). |
| Screening positivity and referral rate | 3 years | Proportion of participants identified as medium/high-risk and referred for further diagnostic imaging (e.g.,pathology/CT/MRI). |
| Overall survival (OS) | 3 years | Indicates whether the participant was alive at the end of follow-up and their survival duration. |
| Screening adherence | 3 years | The proportion of participants who completed biannual AFP and ultrasound screenings as scheduled during follow-up. |
| Model performance in subgroups | 3 years | Subgroup analyses to compare predictive performance of each model in different populations (e.g., by sex, age, ALT level, HBV DNA level). |
| Stage distribution of HCC cases identified by different screening strategies | 3 years | — |
| Early detection rate of HCC cases identified by different screening strategies | 3 years | — |
Countries
China
Contacts
Primary ContactMingfang Ji, MD
Outcome results
None listed