All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. 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 and EBV DNA
Diagnostic testDetect P85-Ab, EBNA1-IgA, VCA-IgA for all participants, and detect EBV DNA for all male participants and P85-Ab positive female participants.
Fiberoptic endoscopy and biopsy
Diagnostic testScreening participants 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
