Nasopharyngeal Carcinoma (NPC)NCT06870435
Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
A study testing Blood, nasopharyngeal swab and saliva, EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA and Novel screening biomarkers in people with Nasopharyngeal Carcinoma (NPC) and Screening, run by Ming-Yuan Chen at 1 site in China.
Trial summary
This study is a prospective, self-controlled, multicenter clinical trial. All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. 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 (NPC), Screening, Epstein Barr Virus
- What is being tested?
- Blood, nasopharyngeal swab and saliva, EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA and Novel screening biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68,649 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2025to 31 Dec 2035
- Phase
- Interventional
- 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
Who may be able to join
- Voluntarily signed informed consent.
- Age between 30 and 69 years at the time of screening.
- Residents of Guangdong Province or Guangxi Province.
- Able to cooperate with long-term follow-up.
Who cannot join
- Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders.
- Severe autoimmune diseases or immunodeficiency.
- History of or current malignant tumors.
- Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.
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
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Ming-Yuan Chen, MD, PhD, +86-13903052650, chmingy@mail.sysu.edu.cn
About this study
Official title: Comparison and Strategy Optimization of Plasma Epstein-Barr Virus (EBV) DNA and BNLF2b Total Antibodies (P85-Ab) with VCA-IgA and EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
This study is a prospective, self-controlled, multicenter clinical trial. All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.
First, it aims to investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening, thereby identifying the optimal initial NPC screening strategy. Based on the determined optimal initial screening strategy, the study will validate the proposed two-step method (subjects first undergo two-antibody method testing and P85-Ab testing; those positive for either one biomarker above proceed to plasma EBV DNA testing; subjects positive in both steps are defined as high-risk and receive endoscopic examinations with or without biopsy) compared with the single-step method (subjects simultaneously undergo two-antibody method testing, P85-Ab testing, and plasma EBV DNA testing; subjects with any positive biomarker undergo endoscopic examinations with or without biopsy) and each single screening testing. The aim is to determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity, thereby enhancing screening efficiency, reducing the rate of invasive procedures (such as endoscopic biopsies), and lowering medical costs and insurance burdens.
- Being tested
- Blood, nasopharyngeal swab and saliva, EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA, Novel screening biomarkers, Endoscopic examinations with or without biopsy
- Keywords
- Nasopharyngeal Carcinoma (NPC), Screening, Epstein Barr Virus, EBV DNA, EBV antibody
- Medical subject headings
- Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, nasopharyngeal swab and salivaBiological
Collect blood, nasopharyngeal swab and saliva samples from participants.
EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNADiagnostic test
Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants.
Novel screening biomarkersDiagnostic test
Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc..
Endoscopic examinations with or without biopsyDiagnostic test
High-risk participants will refer to endoscopic examinations with or without biopsy
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort | Experimental | Participants aged between 30 and 69 years old. Receives: Biological: Blood, nasopharyngeal swab and saliva; Diagnostic Test: EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA; Diagnostic Test: Novel screening biomarkers; Diagnostic Test: Endoscopic examinations with or without biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing
To investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.
Measured: At screening, 3 years and 10 years thereafter.
Sensitivity and positive predictive value (PPV) of the two-step method, single-step method and each single screening testing.
To determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity. PPV refers to the proportion of positive test results that are true positives. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.
Measured: At screening, 3 years and 10 years thereafter.
Secondary outcomes (5)
Negative predictive value (NPV)
NPV refers to the proportion of positive negative results that are true negatives.
Measured: At screening, 3 years and 10 years thereafter.
Early diagnosis rate of nasopharyngeal carcinoma
The proportion of nasopharyngeal carcinoma patients diagnosed at stages I and II according to the 9th version of AJCC TNM system.
Measured: At screening, 3 years and 10 years thereafter.
Number needed to screen (NNS)
NNS refers to the amount of screening participants to identify one nasopharyngeal carcinoma case.
Measured: At screening, 3 years and 10 years thereafter.
Nasopharyngeal Carcinoma Death Rates
Nasopharyngeal Carcinoma deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
Measured: At screening, 3 years and 10 years thereafter.
Death Rates From All Causes
Deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
Measured: At screening, 3 years and 10 years thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start24 Jan 2025
- Primary completion23 Jan 2026 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.
- Masking
- None (open label)
- Enrolment
- 68,649 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-yuan Chen, MD, PhD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870435
- Sponsor's protocol ID
- ZDWY.BYAFZZX.032
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison and Strategy Optimization of Plasma Epstein-Barr Virus (EBV) DNA and BNLF2b Total Antibodies (P85-Ab) with VCA-IgA and EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
- ClinicalTrials.gov ID
- NCT06870435
- Acronym / sponsor ID
- ZDWY.BYAFZZX.032
- Keywords
- Nasopharyngeal Carcinoma (NPC), Screening, Epstein Barr Virus, EBV DNA, EBV antibody
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68,649 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 23 Jan 2026 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 11 Mar 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.
This study is a prospective, self-controlled, multicenter clinical trial. All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.
First, it aims to investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening, thereby identifying the optimal initial NPC screening strategy. Based on the determined optimal initial screening strategy, the study will validate the proposed two-step method (subjects first undergo two-antibody method testing and P85-Ab testing; those positive for either one biomarker above proceed to plasma EBV DNA testing; subjects positive in both steps are defined as high-risk and receive endoscopic examinations with or without biopsy) compared with the single-step method (subjects simultaneously undergo two-antibody method testing, P85-Ab testing, and plasma EBV DNA testing; subjects with any positive biomarker undergo endoscopic examinations with or without biopsy) and each single screening testing. The aim is to determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity, thereby enhancing screening efficiency, reducing the rate of invasive procedures (such as endoscopic biopsies), and lowering medical costs and insurance burdens.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.
| Arm | Type | Receives |
|---|---|---|
| Screening cohort | Experimental | Biological: Blood, nasopharyngeal swab and saliva, Diagnostic Test: EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA, Diagnostic Test: Novel screening biomarkers, Diagnostic Test: Endoscopic examinations with or without biopsyParticipants aged between 30 and 69 years old. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily signed informed consent.
- Age between 30 and 69 years at the time of screening.
- Residents of Guangdong Province or Guangxi Province.
- Able to cooperate with long-term follow-up.
Key exclusion criteria (4 listed)
- Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders.
- Severe autoimmune diseases or immunodeficiency.
- History of or current malignant tumors.
- Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.
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, nasopharyngeal swab and salivaCollect blood, nasopharyngeal swab and saliva samples from participants. | Biological | Screening cohort |
| EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNADetect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants. | Diagnostic test | Screening cohort |
| Novel screening biomarkersNext-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc.. | Diagnostic test | Screening cohort |
| Endoscopic examinations with or without biopsyHigh-risk participants will refer to endoscopic examinations with or without biopsy | Diagnostic test | Screening cohort |
Primary outcome
Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing
Time frame: At screening, 3 years and 10 years thereafter.
To investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.
Sensitivity and positive predictive value (PPV) of the two-step method, single-step method and each single screening testing.
Time frame: At screening, 3 years and 10 years thereafter.
To determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity. PPV refers to the proportion of positive test results that are true positives. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.
5 secondary outcomes
Negative predictive value (NPV)
Time frame: At screening, 3 years and 10 years thereafter.
Early diagnosis rate of nasopharyngeal carcinoma
Time frame: At screening, 3 years and 10 years thereafter.
Number needed to screen (NNS)
Time frame: At screening, 3 years and 10 years thereafter.
Nasopharyngeal Carcinoma Death Rates
Time frame: At screening, 3 years and 10 years thereafter.
Death Rates From All Causes
Time frame: At screening, 3 years and 10 years thereafter.
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 11 Mar 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.
Ming-yuan Chen, MD, PhD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, nasopharyngeal swab and saliva, EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA and Novel screening biomarkers in people with Nasopharyngeal Carcinoma (NPC) and Screening, run by Ming-Yuan Chen 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 11 Mar 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 Ming-yuan Chen, MD, PhD (86-13903052650, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing (time frame: At screening, 3 years and 10 years thereafter.). 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?
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 11 Mar 2025.