Screening for Early Diagnosis of Nose Cancer

National University Health System (NUHS)

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma

Treatments: Diagnostic Test: EBV biomarker testing

Study type: Interventional

Funder types: Other

Identifiers

NCT07019870

2022/00507

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20,000 participants in 2 patient groups

High Risk Individuals

Other group

Description:

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.

Treatment:

Diagnostic Test: EBV biomarker testing

Low Risk Individuals

Other group

Description:

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.

Treatment:

Diagnostic Test: EBV biomarker testing