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

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

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

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Diagnostic test: EBV antibodies test; Diagnostic test: EBV DNA test

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 Type: Observational
• Enrollment (Anticipated): 11625

Contacts and Locations

• Study Contact: Name: Si-Yuan Chen, MD; Phone Number: 86-18711150216; Email: chensy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 62 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Residences in Southern China

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High risk population of nasopharyngeal carcinoma; first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Wuzhou Red Cross Hospital; Xiangya Hospital of Central South University; Hunan Cancer Hospital; First People's Hospital of Foshan; Zhongshan People's Hospital, Guangdong, China; The Third Affiliated Hospital of Nanchang University; Yuebei People's Hospital; Changsha Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 10, 2022
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2030

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: EBV DNA; Nasopharyngeal Carcinoma Screen; EBV antibody
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; DNA Virus Infections; Tumor Virus Infections; Herpesviridae Infections; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Epstein-Barr Virus Infections; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: SYSUCC-CMY-2022-screen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No