Clinical trial NCT07010198: Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
Official title: Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Cancer (HCC)
Keywords: Screening
Hepatocellular Cancer
aMAP
Lead sponsor: Zhongshan People's Hospital, Guangdong, China
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 4500
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of HCC
timeFrame: 3 years
measure: Predictive performance (Sensitivity, Specificity, Positive Predictive value, AUC, etc.)
timeFrame: 3 years
measure: Risk stratification accuracy
timeFrame: 3 years
Secondary outcomes:
measure: Screening positivity and referral rate
timeFrame: 3 years
measure: Stage distribution of HCC cases identified by different screening strategies
timeFrame: 3 years
measure: Early detection rate of HCC cases identified by different screening strategies
timeFrame: 3 years
measure: Number Needed to Screen (NNS)
timeFrame: 3 years
measure: Incremental Cost-Effectiveness Ratio (ICER)
timeFrame: 3 years
measure: Time-dependent AUC or C-index
timeFrame: 3 years
measure: Model performance in subgroups
timeFrame: 3 years
measure: Overall survival (OS)
timeFrame: 3 years
measure: Screening adherence
timeFrame: 3 years
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
Study officials:
References: