Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma Screen, EBV DNA, EBV antibody
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.
Interventions
DIAGNOSTIC_TESTEBV antibodies test
ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma
DIAGNOSTIC_TESTEBV DNA test
quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma
Sponsors
Wuzhou Red Cross Hospital
Zhongshan People's Hospital, Guangdong, China
Hunan Cancer Hospital
The Third Affiliated Hospital of Nanchang University
First People's Hospital of Foshan
Yuebei People's Hospital
Xiangya Hospital of Central South University
Changsha Central Hospital
Sun Yat-sen University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
30 Years to 62 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| sensitivity | 3 years | the percentage of subjects who test positive to those who have nasopharyngeal carcinoma |
| 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 |
| cost-effectiveness | 3 years | the cost of detecting one nasopharyngeal carcinoma case |
Countries
China
Contacts
Primary ContactMing-Yuan Chen, MD, PhD
Backup ContactSi-Yuan Chen, MD
Outcome results
None listed