Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood, nasopharyngeal swab and saliva: Collect blood, nasopharyngeal swab and saliva samples from participants.

EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA: Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants.

Novel screening biomarkers: Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc..

Endoscopic examinations with or without biopsy: High-risk participants will refer to endoscopic examinations with or without biopsy

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing — 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. — 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.

Trial sites (1)

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