Actively Recruiting
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
Led by Ming-Yuan Chen · Updated on 2025-03-11
68649
Participants Needed
1
Research Sites
518 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating new screening methods for nasopharyngeal carcinoma (NPC) in people at high risk, focusing on Epstein-Barr virus (EBV) associated biomarkers. This study compares plasma EBV DNA testing and BNLF2b total antibodies (P85-Ab) with the current standard two-antibody method (VCA-IgA and EBNA1-IgA). The goal is to find the best initial screening approach that improves detection sensitivity while keeping accuracy high, which could reduce the need for invasive procedures and lower medical costs. Participants between 30 and 69 years old will have blood, nasopharyngeal swab, and saliva samples collected for testing various EBV biomarkers. The study will explore both a two-step screening method—starting with antibody tests followed by plasma EBV DNA testing for positive cases—and a single-step method where all tests are done simultaneously. Those identified as high-risk will undergo endoscopic examinations, with or without biopsy, to confirm findings. Participants will be followed and tested at the start, then again at 3 years and 10 years to measure the sensitivity, specificity, predictive values, and early diagnosis rates of each screening method. Researchers will also monitor death rates related to NPC and all causes. The study is designed to track these outcomes over a long period while ensuring participants can cooperate with ongoing follow-up to assess the screening strategies' effectiveness and efficiency.
CONDITIONS
Brief Title
Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants undergo blood, nasopharyngeal swab, and saliva sample collections to detect EBNA1-IgA, VCA-IgA, P85-Ab, and EBV DNA, including next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs. High-risk participants may be referred to endoscopic examinations with or without biopsy.
Visits at screening, 3 years, and 10 years thereafter
Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
Research Team
M
Ming-yuan Chen, MD, PhD
J
Jiong-lin Liang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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