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.
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.
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.
Single group
Blood, nasopharyngeal swab and saliva
Biological/VaccineCollect blood, nasopharyngeal swab and saliva samples from participants.
EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA
Diagnostic testDetect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants.
Novel screening biomarkers
Diagnostic testNext-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc..
Endoscopic examinations with or without biopsy
Diagnostic testHigh-risk participants will refer to endoscopic examinations with or without biopsy
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.
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.
Negative predictive value (NPV)
NPV refers to the proportion of positive negative results that are true negatives.
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.
Number needed to screen (NNS)
NNS refers to the amount of screening participants to identify one nasopharyngeal carcinoma case.
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.
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Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
