NCT07019870

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.

  • 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.
  • 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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2022Nov 2027

Study Start

First participant enrolled

November 8, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

June 5, 2025

Last Update Submit

June 5, 2025

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal CarcinomaCommunity screeningEBV IgA serologyPlasma EBV DNA

Outcome Measures

Primary Outcomes (3)

  • Stage distribution of NPC

    Stage distribution of NPC diagnosed in study participants, compared to stage distribution of NPC in unscreened individuals routinely diagnosed in the clinic.

    From enrollment of the participant to follow-up at three years

  • Accuracy of EBV IgA serology in identifying NPC cases

    Accuracy of EBV IgA serology including sensitivity, specificity, positive predictive value and negative predictive value

    From enrollment of the participant to follow-up at three years

  • Accuracy of plasma EBV DNA in identifying NPC cases

    Accuracy of plasma EBV DNA including sensitivity, specificity, positive predictive value and negative predictive value

    From enrollment of the participant to follow-up at three years

Study Arms (2)

High Risk Individuals

OTHER

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.

Diagnostic Test: EBV biomarker testing

Low Risk Individuals

OTHER

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.

Diagnostic Test: EBV biomarker testing

Interventions

EBV biomarker testingDIAGNOSTIC_TEST

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.

High Risk IndividualsLow Risk Individuals

Eligibility Criteria

Age35 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale (n = 15,000) and female (n = 5000)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese, Malay, and mixed ethnicities
  • individuals not diagnosed with NPC
  • individuals with family history of NPC

You may not qualify if:

  • younger than 35, older than 60
  • individuals already diagnosed with NPC
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, Singapore

RECRUITING

National University Polyclinics

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Kwok Seng Loh, MBBS, FRCS

    National University Health System, Singapore

    PRINCIPAL INVESTIGATOR

  • Joshua K Tay, MBBS, PhD

    National University Health System, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serene Siow

CONTACT

(65) 6772 3850entsch@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Laboratories performing the EBV EA IgA serology and plasma EBV DNA are blinded to the clinical outcome of the participants.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 13, 2025

Study Start

November 8, 2022

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations

SG(2)