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

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Diagnostic Test: EBV antibodies test; Diagnostic Test: EBV DNA test

• Registration Number: NCT05447169
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-03
• Last Update Submitted: 2022-07-06
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-08
• Study Start: 2022-07-10
• Primary Completion: 2025-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 11625

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk population of nasopharyngeal carcinoma	EBV antibodies test	first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male
High risk population of nasopharyngeal carcinoma	EBV DNA test	first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male

Primary Outcome Measures

Name	Time	Method
positive predictive value	3 years	the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results
negative predictive value	3 years	the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China