The study includes two cohorts: (1) a serological screening cohort; (2) a serological and EBV DNA screening cohort. All participants will be tested for EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab), with additional plasma EBV DNA testing in the latter cohort. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
Subject residents in Zhongshan City or Wuzhou City
Subject has no medical record of nasopharyngeal carcinoma
ECOG 0-2
Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
Subject has heavy cardiovascular, liver or kidney disease.
Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
30-69 years old healthy residences in Zhongshan City and Wuzhou City.
Cohort
Prospective
Blood and saliva
Biological/VaccineCollect blood and saliva samples from participants
P85-Ab, EBNA1-IgA, VCA-IgA
Diagnostic testDetect P85-Ab, EBNA1-IgA, VCA-IgA for all participants.
Consecutive EBV DNA testing
Diagnostic testAll participants undergo baseline EBV DNA testing. Those with positive results are invited for repeat testing approximately 4 weeks later. Consecutive positivity is defined as positive results at both tests.
Fiberoptic endoscopy and biopsy
Diagnostic testScreening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy
Fiberoptic endoscopy and biopsy
Diagnostic testScreening participants with high risk or P85-Ab positive or consecutive EBV DNA positive will refer to fiberoptic endoscopy and biospy
Sensitivity and specificity of different EBV associated biomarkers
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
Positive and negative predictive values of different EBV associated biomarkers
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC
Number needed to screen to identify one nasopharyngeal carcinoma
To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers
Early diagnosis rate of nasopharyngeal carcinoma
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma
The health economic benefits of different biomarkers for nasopharyngeal carcinoma
To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers
New screening strategy of nasopharyngeal carcinoma screening
Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma
Click on the lead sponsor to view all of their trials.
Zhongshan People's Hospital, Guangdong, China
Lead sponsor
Wuzhou Red Cross Hospital
Collaborator
Xiamen University
Collaborator
