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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Blood, nasopharyngeal swab and saliva
  Collect blood, nasopharyngeal swab and saliva samples from participants.
• Диагностический тест EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA
  Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants.
• Диагностический тест Novel screening biomarkers
  Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc..
• Диагностический тест Endoscopic examinations with or without biopsy
  High-risk participants will refer to endoscopic examinations with or without biopsy

Первичные конечные точки

• Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing [Срок оценки: 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. [Срок оценки: At screening, 3 years and 10 years thereafter.]

Вторичные конечные точки (5)

• Negative predictive value (NPV) [Срок оценки: At screening, 3 years and 10 years thereafter.]
• Early diagnosis rate of nasopharyngeal carcinoma [Срок оценки: At screening, 3 years and 10 years thereafter.]
• Number needed to screen (NNS) [Срок оценки: At screening, 3 years and 10 years thereafter.]
• Nasopharyngeal Carcinoma Death Rates [Срок оценки: At screening, 3 years and 10 years thereafter.]
• Death Rates From All Causes [Срок оценки: At screening, 3 years and 10 years thereafter.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Китай · 1 центр

• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai

Идентификаторы

NCT: NCT06870435 · ZDWY.BYAFZZX.032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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