Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood, nasopharyngeal swab and saliva, EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA, Novel screening biomarkers, Endoscopic examinations with or without biopsy.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma (NPC), Screening, Epstein Barr Virus. Basic parameters: 30 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Biological Blood, nasopharyngeal swab and saliva
Collect blood, nasopharyngeal swab and saliva samples from participants. - Diagnostic test EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA
Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants. - Diagnostic test Novel screening biomarkers
Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc.. - Diagnostic test Endoscopic examinations with or without biopsy
High-risk participants will refer to endoscopic examinations with or without biopsy
Primary outcome measures
- Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing [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. [Time frame: At screening, 3 years and 10 years thereafter.]
Secondary outcome measures (5)
- Negative predictive value (NPV) [Time frame: At screening, 3 years and 10 years thereafter.]
- Early diagnosis rate of nasopharyngeal carcinoma [Time frame: At screening, 3 years and 10 years thereafter.]
- Number needed to screen (NNS) [Time frame: At screening, 3 years and 10 years thereafter.]
- Nasopharyngeal Carcinoma Death Rates [Time frame: At screening, 3 years and 10 years thereafter.]
- Death Rates From All Causes [Time frame: At screening, 3 years and 10 years thereafter.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 1 center
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
Identifiers
NCT: NCT06870435 · ZDWY.BYAFZZX.032