Screening for Early Diagnosis of Nose Cancer

Not Applicable

Recruiting

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT07019870
• Lead Sponsor: National University Hospital, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

National University Hospital; 🇸🇬 Singapore, Singapore

National University Polyclinics; 🇸🇬 Singapore, Singapore