Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sun Yat-sen University
- Enrollment
- 11,625
- Locations
- 1
- Primary Endpoint
- positive predictive value
Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 62 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •residents in Southern China
- •30-62 years old
- •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
Outcomes
Primary Outcomes
positive predictive value
Time Frame: 3 years
the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results
negative predictive value
Time Frame: 3 years
the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results
Secondary Outcomes
- specificity(3 years)
- early diagnose rate(3 years)
- sensitivity(3 years)
- cost-effectiveness(3 years)
Investigators
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University