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

March 6, 2025 updated by: Ming-Yuan Chen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68649

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening cohort
Participants aged between 30 and 69 years old.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.
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.
To determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity. PPV refers to the proportion of positive test results that are true positives. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.
At screening, 3 years and 10 years thereafter.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value (NPV)
Time Frame: At screening, 3 years and 10 years thereafter.
NPV refers to the proportion of positive negative results that are true negatives.
At screening, 3 years and 10 years thereafter.
Early diagnosis rate of nasopharyngeal carcinoma
Time Frame: At screening, 3 years and 10 years thereafter.
The proportion of nasopharyngeal carcinoma patients diagnosed at stages I and II according to the 9th version of AJCC TNM system.
At screening, 3 years and 10 years thereafter.
Number needed to screen (NNS)
Time Frame: At screening, 3 years and 10 years thereafter.
NNS refers to the amount of screening participants to identify one nasopharyngeal carcinoma case.
At screening, 3 years and 10 years thereafter.
Nasopharyngeal Carcinoma Death Rates
Time Frame: At screening, 3 years and 10 years thereafter.
Nasopharyngeal Carcinoma deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
At screening, 3 years and 10 years thereafter.
Death Rates From All Causes
Time Frame: At screening, 3 years and 10 years thereafter.
Deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
At screening, 3 years and 10 years thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming-Yuan Chen

Investigators

  • Study Chair: Ming-yuan Chen, MD, PhD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Estimated)

January 23, 2026

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.BYAFZZX.032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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