Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
NCT ID: NCT06870435
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68649 participants
INTERVENTIONAL
2025-01-24
2035-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening cohort
Participants aged between 30 and 69 years old.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 autoimmune diseases or immunodeficiency.
* History of or current malignant tumors.
* Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.
30 Years
69 Years
ALL
Yes
Sponsors
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Ming-Yuan Chen
OTHER
Responsible Party
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Ming-Yuan Chen
Professior, Chief physician
Principal Investigators
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Ming-yuan Chen, MD, PhD
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
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The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZDWY.BYAFZZX.032
Identifier Type: -
Identifier Source: org_study_id
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