The goal of this clinical trial is to evaluate the effectiveness of screening in identifying nasopharyngeal cancer (NPC), and evaluate the performance of Epstein-Barr virus (EBV) biomarkers in a community screening setting in Singapore. Participants will assessed for their risk of NPC using EBV Early Antigen (EA) IgA serology and cell-free plasma EBV DNA. If the initial plasma EBV DNA test is positive, a repeat blood sample will be taken and tested. Saliva will also be collected for evaluation of EBV risk strains, but not used for risk evaluation. 1. High risk individuals are determined by: * a positive EBV EA IgA serology test, and/or * two consecutive positive plasma EBV DNA tests High risk individuals will undergo evaluation in the outpatient Otolaryngology clinic. The evaluation includes a head and neck examination, nasoendoscopy and nasopharyngeal biopsy. Clinical data will be collected at yearly intervals, for at least 3 years, with annual clinical examination and blood tests. 2. Low risk individuals are determined by: * a negative EBV EA IgA serology, and * a negative plasma EBV DNA test, or an initially positive plasma EBV DNA test followed by a negative plasma EBV DNA test on repeat blood taking. Low risk individuals will be contacted via phone call every year for at least 3 years to confirm their disease status. Records will also be reviewed at the National Registry of Disease Office, Health Promotion Board, to confirm that the participant has not been diagnosed with nasopharyngeal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
20,000
15 ml of blood will be collected for EBV EA IgA serology and plasma EBV DNA testing by a trained nursing/phlebotomy staff. If the initial plasma EBV DNA test is positive, a second blood draw will be performed for repeat plasma EBV DNA testing. Additionally, 2-3 ml of saliva will be collected for EBV strain identification, however, this information is not used for risk stratification in this study. Demographic characteristics, clinical history and symptoms will be collected through a questionnaire.
National University Hospital
Singapore, Singapore
RECRUITINGNational University Polyclinics
Singapore, Singapore
RECRUITINGStage distribution of NPC
Stage distribution of NPC diagnosed in study participants, compared to stage distribution of NPC in unscreened individuals routinely diagnosed in the clinic.
Time frame: From enrollment of the participant to follow-up at three years
Accuracy of EBV IgA serology in identifying NPC cases
Accuracy of EBV IgA serology including sensitivity, specificity, positive predictive value and negative predictive value
Time frame: From enrollment of the participant to follow-up at three years
Accuracy of plasma EBV DNA in identifying NPC cases
Accuracy of plasma EBV DNA including sensitivity, specificity, positive predictive value and negative predictive value
Time frame: From enrollment of the participant to follow-up at three years
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