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NCT Number: NCT07019870

Screening for Early Diagnosis of Nose Cancer

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.

Recruiting

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Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBV biomarker testing

Diagnostic 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.

Primary outcomes

  1. Stage distribution of NPC

    Time frame: 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.

  2. Accuracy of EBV IgA serology in identifying NPC cases

    Time frame: 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

  3. Accuracy of plasma EBV DNA in identifying NPC cases

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Serene Siow

CONTACT

[email protected]

(65) 6772 3850

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • Genome Institute of Singapore
  • National Medical Research Council (NMRC), Singapore
  • National University of Singapore
  • Pathnova Laboratories, Singapore

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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