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Recruiting NCT05447169

Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening

— Observational Nasopharyngeal Carcinoma

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: EBV antibodies test, EBV DNA test.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 30 years — 62 years · Male.
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 →

Unsure about the terms? Read our patient guide →

Official title

Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population

Overview

The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.

Detailed description

The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.

Interventions

  • Diagnostic test EBV antibodies test
    ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma
  • Diagnostic test EBV DNA test
    quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

Primary outcome measures

  • positive predictive value [Time frame: 3 years]
  • negative predictive value [Time frame: 3 years]
Secondary outcome measures (4)
  • sensitivity [Time frame: 3 years]
  • specificity [Time frame: 3 years]
  • early diagnose rate [Time frame: 3 years]
  • cost-effectiveness [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • residents in Southern China
  • 30-62 years old
  • male
  • a first-degree relative of at least one nasopharyngeal carcinoma patient
  • no medical record of nasopharyngeal carcinoma
  • Eastern Cooperative Oncology Group score of 0-2
  • be able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion criteria

  • history of nasopharyngeal carcinoma
  • heavy cardiovascular, liver or kidney disease
  • on systemic steroid or immunosuppressant treatment or active autoimmune disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

China · 1 center
  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT05447169 · SYSUCC-CMY-2022-screen

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗