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NCT Number: NCT07010198

Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City

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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Key information

Conditions

Hepatocellular Cancer (HCC) Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

Location status: Recruiting

Location contact

Mingfang Ji, MD

CONTACT

[email protected]

86-0760-89880417

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative HBeAg Testing

Diagnostic Test

Quantitative HBeAg Testing in Population-Based Primary Screening

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

Primary outcomes

  1. Incidence of HCC

    Time frame: 3 years

    The number of newly diagnosed HCC cases divided by total person-years at risk during follow-up for each screening strategy.

  2. Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.)

    Time frame: 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.

  3. Risk stratification accuracy

    Time frame: 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 outcomes

  1. Screening positivity and referral rate

    Time frame: 3 years

    Proportion of participants identified as medium/high-risk and referred for further diagnostic imaging (e.g.,pathology/CT/MRI).

  2. Stage distribution of HCC cases identified by different screening strategies

    Time frame: 3 years

  3. Early detection rate of HCC cases identified by different screening strategies

    Time frame: 3 years

  4. Number Needed to Screen (NNS)

    Time frame: 3 years

    Number of individuals needed to be screened to prevent one case of HCC.

  5. Incremental Cost-Effectiveness Ratio (ICER)

    Time frame: 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.

  6. Time-dependent AUC or C-index

    Time frame: 3 years

    Model discrimination assessed at different time points using time-dependent ROC curves and concordance index (C-index).

  7. Model performance in subgroups

    Time frame: 3 years

    Subgroup analyses to compare predictive performance of each model in different populations (e.g., by sex, age, ALT level, HBV DNA level).

  8. Overall survival (OS)

    Time frame: 3 years

    Indicates whether the participant was alive at the end of follow-up and their survival duration.

  9. Screening adherence

    Time frame: 3 years

    The proportion of participants who completed biannual AFP and ultrasound screenings as scheduled during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingfang Ji, MD

CONTACT

[email protected]

86-0760-89880417

Sponsors and collaborators

Lead sponsor

Zhongshan People's Hospital, Guangdong, China

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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