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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
China
Zhongshan People's Hospital
RECRUITING
Zhongshan
Contact Information
Primary
Mingfang Ji, MD
jmftbh@sina.com
86-0760-89880417
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 4500
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Zhongshan People's Hospital, Guangdong, China

This content was sourced from clinicaltrials.gov