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Screening for Early Diagnosis of Nose Cancer

NCT07019870 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DIAGNOSTIC_TEST

EBV 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.

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Genome Institute of Singapore

    collaborator OTHER

  • Pathnova Laboratories, Singapore

    collaborator UNKNOWN

  • National University of Singapore

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Kwok Seng Loh, MBBS, FRCS · National University Health System, Singapore

  • Joshua K Tay, MBBS, PhD · National University Health System, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07019870 on ClinicalTrials.gov