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

NCT07010198 | Recruiting

• 1 other identifier: HCC-2025-01
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer (HCC)

Keywords

Screening; Hepatocellular Cancer; aMAP

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Screening positivity and referral rate

  3 years

• 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

• Number Needed to Screen (NNS)

  3 years

• Incremental Cost-Effectiveness Ratio (ICER)

  3 years

Study Arms (1)

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

Diagnostic Test: Quantitative HBeAg Testing; Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies; Biological: Follow-Up Monitoring Parameters

Interventions

Quantitative HBeAg Testing DIAGNOSTIC_TEST

Quantitative HBeAg Testing in Population-Based Primary Screening

HCC Screening Dynamic Cohort

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.

HCC Screening Dynamic Cohort

Follow-Up Monitoring Parameters BIOLOGICAL

AFP, Liver Ultrasound

HCC Screening Dynamic Cohort

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Local household-registered residents aged ≥35 years, HBsAg-positive, with no prior diagnosis of HCC, residing in Zhongshan City.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead

Study Sites (1)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Mingfang Ji, MD

CONTACT

86-0760-89880417; jmftbh@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 8, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

CN (1)