Nasopharyngeal CarcinomaNCT07019870
Screening for Early Diagnosis of Nose Cancer
A study testing EBV biomarker testing in people with Nasopharyngeal Carcinoma, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- EBV biomarker testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 2 sitesSingapore
- Study dates
- 8 Nov 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese, Malay, and mixed ethnicities
- individuals not diagnosed with NPC
- individuals with family history of NPC
Who cannot join
- younger than 35, older than 60
- individuals already diagnosed with NPC
- pregnant women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
Serene Siow, (65) 6772 3850, entsch@nus.edu.sg
- Recruiting
National University Polyclinics
Singapore
Serene Siow, (65) 6772 3850, entsch@nus.edu.sg
About this study
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.
Read more
- 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.
- 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
- Being tested
- EBV biomarker testing
- Keywords
- Nasopharyngeal Carcinoma, Community screening, EBV IgA serology, Plasma EBV DNA
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: EBV biomarker testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: From enrollment of the participant to follow-up at three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start8 Nov 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Genome Institute of Singapore, Pathnova Laboratories, Singapore, National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Kwok Seng Loh, MBBS, FRCS, Principal investigator, National University Health System, SingaporeJoshua K Tay, MBBS, PhD, Principal investigator, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019870
- Sponsor's protocol ID
- 2022/00507
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Early Diagnosis of Nose Cancer
- ClinicalTrials.gov ID
- NCT07019870
- Acronym / sponsor ID
- 2022/00507
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Community screening, EBV IgA serology, Plasma EBV DNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Genome Institute of Singapore, Pathnova Laboratories, Singapore, National University of Singapore
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Individuals | Other | Diagnostic Test: EBV biomarker testingHigh 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. |
| Low Risk Individuals | Other | Diagnostic Test: EBV biomarker testingLow 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese, Malay, and mixed ethnicities
- individuals not diagnosed with NPC
- individuals with family history of NPC
Key exclusion criteria (3 listed)
- younger than 35, older than 60
- individuals already diagnosed with NPC
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBV biomarker testing15 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. | Diagnostic test | High Risk Individuals, Low Risk Individuals |
Primary outcome
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kwok Seng Loh, MBBS, FRCS principal investigator
National University Health System, Singapore
Joshua K Tay, MBBS, PhD principal investigator
National University Health System, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBV biomarker testing in people with Nasopharyngeal Carcinoma, run by National University Hospital, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serene Siow ((65) 6772 3850, entsch@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage distribution of NPC (time frame: From enrollment of the participant to follow-up at three years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.