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NCT05447169 Clinical Trial

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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05447169
Other study ID # SYSUCC-CMY-2022-screen
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2022
Est. completion date July 1, 2030

Study information
Verified date July 2022
Source Sun Yat-sen University
Contact Ming-Yuan Chen, MD, PhD
Phone 86-20-8734-3361
Email chmingy@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 11625
Est. completion date July 1, 2030
Est. primary completion date July 1, 2025
Accepts healthy volunteers
Gender Male
Age group 30 Years to 62 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• EBV DNA test
quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

Locations
Country Name City State
China Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (9)
Lead Sponsor Collaborator
Sun Yat-sen University Changsha Central Hospital, First People's Hospital of Foshan, Hunan Cancer Hospital, The Third Affiliated Hospital of Nanchang University, Wuzhou Red Cross Hospital, Xiangya Hospital of Central South University, Yuebei People's Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary positive predictive value the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results 3 years
Primary 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 sensitivity the percentage of subjects who test positive to those who have nasopharyngeal carcinoma 3 years
Secondary specificity the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma 3 years
Secondary early diagnose rate the ratio of patients with stage I and stage II disease to all those who have nasopharyngeal carcinoma 3 years
Secondary cost-effectiveness the cost of detecting one nasopharyngeal carcinoma case 3 years
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