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RecruitingNCT07010198Updated Jun 8, 2025

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

An observational study in Hepatocellular Cancer (HCC), sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by Zhongshan People's Hospital, Guangdong, China · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 8 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,500
Ages
35 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 309 studies in Liver Neoplasms with a site in China — 122 open to participants now, 134 under way, 7 of them phase 3. Liver Neoplasms · China.

Planned enrollment
8th of 74
4,500 · median 305
Started
2025
with 28 others
Observational
74 of 309
43 open now
Primary completion
2025-12
later than 47 of 133 live
Registered
260th of 309
by date

Among the 309 studies in Liver Neoplasms with a site in China, this one is the 8th largest by planned enrollment of the 74 observational ones that give a count, is one of 29 that started in 2025, is one of 74 observational ones, reaches primary completion later than 47 of the 133 other live ones, and was the 260th registered.

Liver Neoplasms

1,346 studies on the registry are indexed under Liver Neoplasms; 335 are open to participants now.

Browse Liver Neoplasms studies →

Open to participants now

122 of the 309 studies in Liver Neoplasms with a site in China are open now. Recruiting first, the newest first:

117 more — sign in →

All 122 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 243 Liver Neoplasms studies recruiting now, 137 (56%) set no upper age limit and 69 (28%) stop at 75 or younger; 14 take children under 18; 34 take healthy volunteers.

This study: 35 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 309 studies in Liver Neoplasms with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Hepatocellular Cancer (HCC)

Browse trials for

Keywords

  • Screening
  • Hepatocellular Cancer
  • aMAP
04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily sign the form.
  • Household registration in Zhongshan City, Guangdong Province.
  • Aged 35 and above.
  • Positive screening result for surface antigen (HBsAg).

Exclusion criteria

Exclusion Criteria:

  • Previous history of liver cancer or liver transplantation.
  • Pregnant women.
  • Severe comorbidities (e.g., end-stage cardiopulmonary diseases, advanced ).
  • Individuals lacking legal capacity or unable to provide .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testQuantitative HBeAg Testing

    Quantitative HBeAg Testing in Population-Based Primary Screening

  • BiologicalMeasurement Indicators Required for Risk Scoring in HCC Screening Strategies

    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.

  • BiologicalFollow-Up Monitoring Parameters

    AFP, Liver Ultrasound

06

What researchers measure

Primary outcomes

  1. Incidence of HCC

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

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

  3. 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.

    Time frame: 3 years

Secondary outcomes

  1. Screening positivity and referral rate

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

    Time frame: 3 years

  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)

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

    Time frame: 3 years

  5. 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.

    Time frame: 3 years

  6. Time-dependent AUC or C-index

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

    Time frame: 3 years

  7. 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).

    Time frame: 3 years

  8. Overall survival (OS)

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

    Time frame: 3 years

  9. Screening adherence

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

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Dec 2025, 9 months after the start.

Of 132 non-industry observational studies under Liver Neoplasms, half reached primary completion within 114 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 172. This study's planned 9 months is below that.

Counting every sponsor, half of 160 studies reached it within 59 months; a quarter within 34 and three quarters within 172.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2025
First posted
Jun 8, 2025
StartActual
Mar 1, 2025
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2028
Last update
Jun 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07010198
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Responsible party
Mingfang Ji (Clinical Professor, Zhongshan People's Hospital, Guangdong, China) — Principal investigator
First posted
Jun 8, 2025
Start date
Mar 1, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 8, 2025

Study contacts

Mingfang Ji, MD
Contact
jmftbh@sina.com
86-0760-89880417

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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