Screening for Early Diagnosis of Nose Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 60
Healthy Volunteers: t
View:

• Chinese, Malay, and mixed ethnicities

• individuals not diagnosed with NPC

• individuals with family history of NPC

Locations
Other Locations
Singapore
National University Hospital
RECRUITING
Singapore
National University Polyclinics
RECRUITING
Singapore
Contact Information
Primary
Serene Siow
entsch@nus.edu.sg
(65) 6772 3850
Time Frame
Start Date: 2022-11-08
Estimated Completion Date: 2027-11
Participants
Target number of participants: 20000
Treatments
Other: High Risk Individuals
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.
Other: Low Risk Individuals
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.
Related Therapeutic Areas
Sponsors
Collaborators: Genome Institute of Singapore, National University of Singapore, National Medical Research Council (NMRC), Singapore, Pathnova Laboratories, Singapore
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov