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

RecruitingNAAges 30 Years - 69 YearsAllMing-Yuan Chen
NCT06870435 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Blood, nasopharyngeal swab and saliva
  • EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA
  • Novel screening biomarkers
  • Endoscopic examinations with or without biopsy
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Where

1 site
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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