ClinicalTrials.gg
RecruitingNCT04085900Updated Sep 29, 2026

Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

An observational study in Nasopharyngeal Carcinoma, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 2 sites in China. Open to participants aged 30 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

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

From the registry’s dates

  • Started Apr 2020; still recruiting 6 years 7 months later.
Updated Sep 29, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40,000
Ages
30 Years to 69 Years
Sex
All
01

Where this study stands

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

Among 489 studies in Nasopharyngeal Carcinoma with a site in China — 203 open to participants now, 254 under way, 86 of them phase 3. Nasopharyngeal Carcinoma · China.

Planned enrollment
3rd of 72
40,000 · median 429
Started
2020
with 35 others
Observational
72 of 489
31 open now
Primary completion
2025-12
later than 81 of 253 live
Registered
183rd of 489
by date

Among the 489 studies in Nasopharyngeal Carcinoma with a site in China, this one is the 3rd largest by planned enrollment of the 72 observational ones that give a count, is one of 36 that started in 2020, is one of 72 observational ones, reaches primary completion later than 81 of the 253 other live ones, and was the 183rd registered.

Nasopharyngeal Carcinoma

683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.

Browse Nasopharyngeal Carcinoma studies →

Open to participants now

203 of the 489 studies in Nasopharyngeal Carcinoma with a site in China are open now. Recruiting first, the newest first:

198 more — sign in →

All 203 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 186 Nasopharyngeal Carcinoma studies recruiting now, 42 (23%) set no upper age limit and 135 (73%) stop at 75 or younger; 9 take children under 18; 8 take healthy volunteers.

This study: 30 Years to 69 Years · 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 489 studies in Nasopharyngeal Carcinoma with a site in China, or all of them as a file.
02

Study summary

The study includes two cohorts: (1) a serological screening cohort; (2) a serological and EBV DNA screening cohort. All participants will be tested for EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab), with additional plasma EBV DNA testing in the latter cohort. Screening positive participants will be followed up annually.

All subjects will also be followed by record linkage to Cancer Register and Population Register.

Read the detailed description

Sample selection

- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.

Participants recruitment

  • Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
  • Face-to-face interviews are conducted by well-trained investigators.

Tests and follow up

  • At initial screening, all participants in both cohorts will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in the serological and EBV DNA screening cohort, EBV-DNA will be tested. Consecutive EBV DNA positivity is defined as positive plasma EBV DNA results at both baseline and repeat testing approximately 4 weeks later. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or consecutive EBV DNA positive. The rest will be screening negative.
  • During the initial screening and following up, people with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
  • Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
  • EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
  • The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
  • All subjects will also be followed by record linkage to Cancer Register and Population Register.
03

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • Screening
  • Nasopharyngeal Carcinoma
  • Biomarker
04

Who can participate

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

30-69 years old healthy residences in Zhongshan City and Wuzhou 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

  • Subject residents in Zhongshan City or Wuzhou City
  • Subject has no medical record of nasopharyngeal carcinoma
  • 0-2
  • Subject is able to comprehend, sign, and date the written document to participate in the study.
  • Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.

Exclusion criteria

Exclusion Criteria:

  • Subject has heavy cardiovascular, liver or kidney disease.
  • Subject has to nasopharyngeal fiberoptic endoscopy.
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.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Serological screening cohort

    30-69 years old healthy participants.

    Biological: Blood and saliva · Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA · Diagnostic Test: Fiberoptic endoscopy and biopsy

  • Serological and EBV DNA screening cohort

    30-69 years old healthy participants.

    Biological: Blood and saliva · Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA · Diagnostic Test: Consecutive EBV DNA testing · Diagnostic Test: Fiberoptic endoscopy and biopsy

Interventions

  • BiologicalBlood and saliva

    Drug page: Whole blood

    Collect blood and saliva samples from participants

  • Diagnostic testP85-Ab, EBNA1-IgA, VCA-IgA

    Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants.

  • Diagnostic testConsecutive EBV DNA testing

    All participants undergo baseline EBV DNA testing. Those with positive results are invited for repeat testing approximately 4 weeks later. Consecutive positivity is defined as positive results at both tests.

  • Diagnostic testFiberoptic endoscopy and biopsy

    Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy

  • Diagnostic testFiberoptic endoscopy and biopsy

    Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of different EBV associated biomarkers

    To compare the sensitivity and specificity of different EBV associated biomarkers for NPC

    Time frame: 5 years

  2. Positive and negative predictive values of different EBV associated biomarkers

    To compare the positive and negative predictive values of different EBV associated biomarkers for NPC

    Time frame: 5 years

Secondary outcomes

  1. Number needed to screen to identify one nasopharyngeal carcinoma

    To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers

    Time frame: 5 years

  2. Early diagnosis rate of nasopharyngeal carcinoma

    To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma

    Time frame: 5 years

Other outcomes

  1. The health economic benefits of different biomarkers for nasopharyngeal carcinoma

    To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers

    Time frame: 5 years

  2. New screening strategy of nasopharyngeal carcinoma screening

    Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma

    Time frame: 5 years

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Li T, Li F, Guo X, Hong C, Yu X, Wu B, Lian S, Song L, Tang J, Wen S, Gao K, Hao M, Cheng W, Su Y, Zhang S, Huang S, Fang M, Wang Y, Ng MH, Chen H, Luo W, Ge S, Zhang J, Xia N, Ji M. Anti-Epstein-Barr Virus BNLF2b for Mass Screening for Nasopharyngeal Cancer. N Engl J Med. 2023 Aug 31;389(9):808-819. doi: 10.1056/NEJMoa2301496. PubMed 37646678 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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

Ran from Apr 2020 to primary completion in Dec 2025, 68 months.

Of 52 observational studies under Nasopharyngeal Carcinoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 155. This study's 68 months is above that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Dec 2024 → Dec 2025 and completion Dec 2027 → Dec 2030.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Sep 9, 2019
First posted
Sep 11, 2019
StartActual
Apr 1, 2020
Primary completionActual
Dec 31, 2025was Dec 2024
CompletionEst.
Dec 31, 2030was Dec 2027
Last update
Sep 29, 2026
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.
Primary completion
Dec 31, 2024→Dec 31, 2025 (actual)
Sep 29, 2026
Study completion
Dec 31, 2027→Dec 31, 2030
Sep 29, 2026
Interventions
Changed P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA→P85-Ab, EBNA1-IgA, VCA-IgA. Added Diagnostic test: Consecutive EBV DNA testing·Diagnostic test: Fiberoptic endoscopy and biopsy. Arm changed Screening cohort→Serological screening cohort. Arms added: Serological and EBV DNA screening cohort
Sep 29, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 37646678 ↗
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 37646678 ↗
    Primary completion Dec 31, 2024→Dec 31, 2025 (now actual)
    Study completion Dec 31, 2027→Dec 31, 2030
    Interventions Changed P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA→P85-Ab, EBNA1-IgA, VCA-IgA. Added Diagnostic test: Consecutive EBV DNA testing·Diagnostic test: Fiberoptic endoscopy and biopsy. Arm changed Screening cohort→Serological screening cohort. Arms added: Serological and EBV DNA screening cohort
    + 5 other changes: verification date, oversight details, description, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04085900
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborators
Wuzhou Red Cross Hospital, Xiamen University
Responsible party
Mingfang Ji (Dr. Mingfang Ji, Zhongshan People's Hospital, Guangdong, China) — Principal investigator
First posted
Sep 11, 2019
Start date
Apr 1, 2020
Primary completion
Dec 31, 2025
Completion
Dec 31, 2030 (estimated)
Last update
Sep 29, 2026

Study contacts

Mingfang Ji, MD
Contact
jmftbh@sina.com
86-760-89880417
Mingfang Ji, MD
principal investigator · Zhongshan People's Hospital, Guangdong, China

Oversight

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

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