Clinical Trial

Screening for Early Diagnosis of Nose Cancer

Recruiting
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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.
Trial Details
NCT Number NCT07019870
Lead Sponsor National University Hospital, Singapore
Collaborators: National Medical Research Council (NMRC), Singapore, Genome Institute of Singapore, Pathnova Laboratories, Singapore, National University of Singapore
Conditions Nasopharyngeal Carcinoma
Enrollment 20,000 participants
Start Date 2022-11-08
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2025-06-13