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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

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

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.
02

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • Screening
  • Nasopharyngeal Carcinoma
  • Biomarker
03

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.

Inclusion criteria

  • Subject residents in Zhongshan City or Wuzhou City
  • Subject has no medical record of nasopharyngeal carcinoma
  • ECOG 0-2
  • Subject is able to comprehend, sign, and date the written informed consent 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 contraindications to nasopharyngeal fiberoptic endoscopy.
04

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

    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

05

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

06

Study locations

2 of 2 sites recruiting
  • Zhongshan People's Hospital
    Zhongshan, Guangdong 528403, China
    • Mingfang Ji, MD · Contact · jmftbh@sina.com
    • Mingfang Ji, MD · Principal investigator
    Recruiting
  • Wuzhou Red Cross Hospital
    Wuzhou, Guangxi 543002, China
    Recruiting
07

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 ↗
08

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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