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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
68,649
Collect blood, nasopharyngeal swab and saliva samples from participants.
Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants.
Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc..
High-risk participants will refer to endoscopic examinations with or without biopsy
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGSensitivity 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.
Time frame: 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.
Time frame: At screening, 3 years and 10 years thereafter.
Negative predictive value (NPV)
NPV refers to the proportion of positive negative results that are true negatives.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At screening, 3 years and 10 years thereafter.
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