Nasopharyngeal CarcinomaNCT04085900
Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City
An observational study of Nasopharyngeal Carcinoma, run by Zhongshan People's Hospital, Guangdong, China at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Blood and saliva, P85-Ab, EBNA1-IgA, VCA-IgA and Consecutive EBV DNA testing
- How many people
- 40,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2020to 31 Dec 2030
- How long will I take part?
- 5 Years
- 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 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Who may be able to join
- 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.
Who cannot join
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
Yonglin Cai, MD, cylzen@hotmail.com
Yonglin Cai, MD
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Mingfang Ji, MD, jmftbh@sina.com
Mingfang Ji, MD
About this study
Official title: Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Blood and saliva, P85-Ab, EBNA1-IgA, VCA-IgA, Consecutive EBV DNA testing, Fiberoptic endoscopy and biopsy
- Keywords
- Screening, Nasopharyngeal Carcinoma, Biomarker
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and salivaBiological
Collect blood and saliva samples from participants
P85-Ab, EBNA1-IgA, VCA-IgADiagnostic test
Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants.
Consecutive EBV DNA testingDiagnostic test
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.
Fiberoptic endoscopy and biopsyDiagnostic test
Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy
Fiberoptic endoscopy and biopsyDiagnostic test
Screening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy
| Study group | Role | What they receive |
|---|---|---|
| Serological screening cohort | 30-69 years old healthy participants. Receives: 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. Receives: Biological: Blood and saliva; Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA; Diagnostic Test: Consecutive EBV DNA testing; Diagnostic Test: Fiberoptic endoscopy and biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of different EBV associated biomarkers
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
Measured: 5 years
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
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
Early diagnosis rate of nasopharyngeal carcinoma
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Apr 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- 40,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Xiamen University
- Responsible party
- Principal investigator, Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
- Investigators
- Mingfang Ji, MD, Principal investigator, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085900
- Sponsor's protocol ID
- NPC-PRO-003
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2019
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
- ClinicalTrials.gov ID
- NCT04085900
- Acronym / sponsor ID
- NPC-PRO-003
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Screening, Nasopharyngeal Carcinoma, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Xiamen University
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Sep 2019 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serological screening cohort | – | Biological: Blood and saliva, Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA, Diagnostic Test: Fiberoptic endoscopy and biopsy30-69 years old healthy participants. |
| Serological and EBV DNA screening cohort | – | Biological: Blood and saliva, Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA, Diagnostic Test: Consecutive EBV DNA testing, Diagnostic Test: Fiberoptic endoscopy and biopsy30-69 years old healthy participants. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
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 |
|---|---|---|
| Blood and salivaCollect blood and saliva samples from participants | Biological | Serological and EBV DNA screening cohort, Serological screening cohort |
| P85-Ab, EBNA1-IgA, VCA-IgADetect P85-Ab, EBNA1-IgA, VCA-IgA for all participants. | Diagnostic test | Serological and EBV DNA screening cohort, Serological screening cohort |
| Consecutive EBV DNA testingAll 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 test | Serological and EBV DNA screening cohort |
| Fiberoptic endoscopy and biopsyScreening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy | Diagnostic test | Serological screening cohort |
| Fiberoptic endoscopy and biopsyScreening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy | Diagnostic test | Serological and EBV DNA screening cohort |
Primary outcome
Sensitivity and specificity of different EBV associated biomarkers
Time frame: 5 years
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
Positive and negative predictive values of different EBV associated biomarkers
Time frame: 5 years
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC
2 secondary outcomes
Number needed to screen to identify one nasopharyngeal carcinoma
Time frame: 5 years
Early diagnosis rate of nasopharyngeal carcinoma
Time frame: 5 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 29 Sep 2026.
- Derived from this study: PubMed 37646678Li 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.
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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.
Mingfang Ji, MD principal investigator
Zhongshan People's Hospital, Guangdong, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Zhongshan People's Hospital, Guangdong, China at 2 sites 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 5 inclusion and 2 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (86-760-89880417, jmftbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of different EBV associated biomarkers (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085900, which also lists 1 linked publication.
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 29 Sep 2026.