Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Community screening, EBV IgA serology, Plasma EBV DNA
Brief summary
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.
Interventions
DIAGNOSTIC_TESTEBV biomarker testing
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.
Sponsors
National Medical Research Council (NMRC), Singapore
Genome Institute of Singapore
Pathnova Laboratories, Singapore
National University of Singapore
National University Hospital, Singapore
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
Laboratories performing the EBV EA IgA serology and plasma EBV DNA are blinded to the clinical outcome of the participants.
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Chinese, Malay, and mixed ethnicities * individuals not diagnosed with NPC * individuals with family history of NPC
Exclusion criteria
* younger than 35, older than 60 * individuals already diagnosed with NPC * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage distribution of NPC | From enrollment of the participant to follow-up at three years | Stage distribution of NPC diagnosed in study participants, compared to stage distribution of NPC in unscreened individuals routinely diagnosed in the clinic. |
| Accuracy of EBV IgA serology in identifying NPC cases | From enrollment of the participant to follow-up at three years | Accuracy of EBV IgA serology including sensitivity, specificity, positive predictive value and negative predictive value |
| Accuracy of plasma EBV DNA in identifying NPC cases | From enrollment of the participant to follow-up at three years | Accuracy of plasma EBV DNA including sensitivity, specificity, positive predictive value and negative predictive value |
Countries
Singapore
Contacts
Primary ContactSerene Siow
Outcome results
None listed