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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Diagnostic Test: EBV antibodies test
* Diagnostic Test: EBV DNA test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk population of nasopharyngeal carcinoma<br>first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male | Diagnostic Test: EBV antibodies test<br>* ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma<br>Diagnostic Test: EBV DNA test<br>* quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive predictive value | the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results | 3 years | 
| negative predictive value | the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity | the percentage of subjects who test positive to those who have nasopharyngeal carcinoma | 3 years | 
| specificity | the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma | 3 years | 
| early diagnose rate | the ratio of patients with stage I and stage II disease to all those who have nasopharyngeal carcinoma | 3 years | 
| cost-effectiveness | the cost of detecting one nasopharyngeal carcinoma case | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma Screen, EBV DNA, EBV antibody