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| Name | Class |
|---|---|
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
| Genome Institute of Singapore | OTHER |
| Pathnova Laboratories, Singapore | UNKNOWN |
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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.
High risk individuals are determined by:
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.
Low risk individuals are determined by:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk Individuals | Other | 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. |
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| Low Risk Individuals | Other | Low risk individuals are determined by: a negative EBV EA IgA serology, and negative plasma EBV DNA test (i.e. 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, to confirm that the participant has not been diagnosed with NPC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV biomarker testing | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 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. | 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 | 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 | From enrollment of the participant to follow-up at three years |
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Inclusion Criteria:
Exclusion Criteria:
Male (n = 15,000) and female (n = 5000)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serene Siow | Contact | (65) 6772 3850 | entsch@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Kwok Seng Loh, MBBS, FRCS | National University Health System, Singapore | Principal Investigator |
| Joshua K Tay, MBBS, PhD | National University Health System, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | Singapore |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| National University of Singapore |
| OTHER |
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Laboratories performing the EBV EA IgA serology and plasma EBV DNA are blinded to the clinical outcome of the participants.
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| National University Polyclinics | Recruiting | Singapore | Singapore |
|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |