Clinical trial NCT07019870: Screening for Early Diagnosis of Nose Cancer
Official title: Screening for Early Diagnosis of Nose Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Community screening
EBV IgA serology
Plasma EBV DNA
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: Genome Institute of Singapore
name: Pathnova Laboratories, Singapore
name: National University of Singapore
First posted: 2025-06-13
Enrollment: 20000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stage distribution of NPC
timeFrame: From enrollment of the participant to follow-up at three years
measure: Accuracy of EBV IgA serology in identifying NPC cases
timeFrame: From enrollment of the participant to follow-up at three years
measure: Accuracy of plasma EBV DNA in identifying NPC cases
timeFrame: From enrollment of the participant to follow-up at three years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National University Polyclinics
Study officials:
affiliation: National University Health System, Singapore
name: Kwok Seng Loh, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Health System, Singapore
name: Joshua K Tay, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: