Hepatocellular Cancer (HCC)NCT07010198
Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
An observational study of Hepatocellular Cancer (HCC), run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Cancer (HCC)
- What is being tested?
- Quantitative HBeAg Testing, Measurement Indicators Required for Risk Scoring in HCC Screening Strategies and Follow-Up Monitoring Parameters
- How many people
- 4,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Local household-registered residents aged ≥35 years, HBsAg-positive, with no prior diagnosis of HCC, residing in Zhongshan City.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Mingfang Ji, MD, 86-0760-89880417, jmftbh@sina.com
About this study
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)
- Being tested
- Quantitative HBeAg Testing, Measurement Indicators Required for Risk Scoring in HCC Screening Strategies, Follow-Up Monitoring Parameters
- Keywords
- Screening, Hepatocellular Cancer, aMAP
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative HBeAg TestingDiagnostic test
Quantitative HBeAg Testing in Population-Based Primary Screening
Measurement Indicators Required for Risk Scoring in HCC Screening StrategiesBiological
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 ParametersBiological
AFP, Liver Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Quantitative HBeAg Testing; Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies; Biological: Follow-Up Monitoring Parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HCC
The number of newly diagnosed HCC cases divided by total person-years at risk during follow-up for each screening strategy.
Measured: 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.
Measured: 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.
Measured: 3 years
Secondary outcomes (9)
Screening positivity and referral rate
Proportion of participants identified as medium/high-risk and referred for further diagnostic imaging (e.g.,pathology/CT/MRI).
Measured: 3 years
Stage distribution of HCC cases identified by different screening strategies
Measured: 3 years
Early detection rate of HCC cases identified by different screening strategies
Measured: 3 years
Number Needed to Screen (NNS)
Number of individuals needed to be screened to prevent one case of HCC.
Measured: 3 years
Incremental Cost-Effectiveness Ratio (ICER)
The additional cost required to gain one extra QALY or to prevent one HCC case using a given model, compared with baseline strategy.
Measured: 3 years
Time-dependent AUC or C-index
Model discrimination assessed at different time points using time-dependent ROC curves and concordance index (C-index).
Measured: 3 years
Model performance in subgroups
Subgroup analyses to compare predictive performance of each model in different populations (e.g., by sex, age, ALT level, HBV DNA level).
Measured: 3 years
Overall survival (OS)
Indicates whether the participant was alive at the end of follow-up and their survival duration.
Measured: 3 years
Screening adherence
The proportion of participants who completed biannual AFP and ultrasound screenings as scheduled during follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Cancer (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010198
- Sponsor's protocol ID
- HCC-2025-01
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-Head Comparison of Hepatocellular Cancer (HCC) Screening Strategies: A Prospective Population-Based Cohort Study in Zhongshan City
- ClinicalTrials.gov ID
- NCT07010198
- Acronym / sponsor ID
- HCC-2025-01
- Conditions
- Hepatocellular Cancer (HCC)
- Keywords
- Screening, Hepatocellular Cancer, aMAP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC Screening Dynamic Cohort | – | Diagnostic Test: Quantitative HBeAg Testing, Biological: Measurement Indicators Required for Risk Scoring in HCC Screening Strategies, Biological: Follow-Up Monitoring ParametersLocal 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 |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Local household-registered residents aged ≥35 years, HBsAg-positive, with no prior diagnosis of HCC, residing in Zhongshan City.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative HBeAg TestingQuantitative HBeAg Testing in Population-Based Primary Screening | Diagnostic test | HCC Screening Dynamic Cohort |
| Measurement Indicators Required for Risk Scoring in HCC Screening StrategiesREACH-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. | Biological | HCC Screening Dynamic Cohort |
| Follow-Up Monitoring ParametersAFP, Liver Ultrasound | Biological | HCC Screening Dynamic Cohort |
Primary outcome
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.
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.
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.
9 secondary outcomes
Screening positivity and referral rate
Time frame: 3 years
Stage distribution of HCC cases identified by different screening strategies
Time frame: 3 years
Early detection rate of HCC cases identified by different screening strategies
Time frame: 3 years
Number Needed to Screen (NNS)
Time frame: 3 years
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 3 years
Time-dependent AUC or C-index
Time frame: 3 years
Model performance in subgroups
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Screening adherence
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Cancer (HCC), run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingfang Ji, MD (86-0760-89880417, jmftbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HCC (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.