Clinical trial NCT06870435: Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma (NPC)
Screening
Epstein Barr Virus
Keywords: Nasopharyngeal Carcinoma (NPC)
Screening
Epstein Barr Virus
EBV DNA
EBV antibody
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 68649
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SCREENING

Brief summary: 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.


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.

Primary outcomes:
measure: Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing
timeFrame: At screening, 3 years and 10 years thereafter.
measure: Sensitivity and positive predictive value (PPV) of the two-step method, single-step method and each single screening testing.
timeFrame: At screening, 3 years and 10 years thereafter.
Secondary outcomes:
measure: Negative predictive value (NPV)
timeFrame: At screening, 3 years and 10 years thereafter.
measure: Early diagnosis rate of nasopharyngeal carcinoma
timeFrame: At screening, 3 years and 10 years thereafter.
measure: Number needed to screen (NNS)
timeFrame: At screening, 3 years and 10 years thereafter.
measure: Nasopharyngeal Carcinoma Death Rates
timeFrame: At screening, 3 years and 10 years thereafter.
measure: Death Rates From All Causes
timeFrame: At screening, 3 years and 10 years thereafter.
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-yuan Chen, MD, PhD
role: STUDY_CHAIR
References: