RecruitingNot ApplicableNCT07019870

Screening for Early Diagnosis of Nose Cancer


Sponsor

National University Hospital, Singapore

Enrollment

20,000 participants

Start Date

Nov 8, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether screening people with a family history of nasopharyngeal carcinoma (NPC, also known as nose cancer) can help catch the disease early, before symptoms appear. You may be eligible if: you are of Chinese, Malay, or mixed ethnicity; you have a family history of NPC; and you have not already been diagnosed with NPC. You may NOT be eligible if: you are younger than 35 or older than 60 years old; or you have already been diagnosed with NPC; or you are pregnant. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(2)

National University Hospital

Singapore, Singapore

National University Polyclinics

Singapore, Singapore

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NCT07019870


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