Nasopharyngeal CarcinomaNCT02063399
Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis
An observational study of Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using plasma Epstein-Barr virus DNA analysis would result in the detecting NPC cases at earlier stages and improve survival. Read more about this study
- Who is it for?
- Ages 40 to 62 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 20,302 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2013to Jun 2030
- Phase
- Observational
- 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 40 to 62 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male Hong Kong residents of Chinese ethnicity
Who may be able to join
- age 40 to 62 years
- ethnic Chinese
- male
Who cannot join
- history of nasopharyngeal carcinoma
- currently having a malignant disease
- active autoimmune disease
- HIV infection
- on systemic steroid treatment
- on immunosuppressant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis
The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using plasma Epstein-Barr virus DNA analysis would result in the detecting NPC cases at earlier stages and improve survival.
Read the detailed description
Epstein-Barr virus (EBV) infection is an important etiological factor for nasopharyngeal carcinoma (NPC). In a pilot study, we have shown that the analysis of Epstein-Barr virus (EBV) DNA in blood can detect early and asymptomatic NPC. However, it is unlcear if NPC screening can improve the prognosis of the screened NPC subjects.
20,000 male subjects aged from 40 to 62 will be recruited because the incidence of NPC is higher in this target group. Twenty millilitres of venous blood will be collected from each subject at enrolment for plasma EBV DNA analysis.
Subjects who have initial positive results for plasma EBV DNA will have another testing at approximately 4 weeks. Subjects who have persistently positive results for the two plasma EBV DNA analyses will be investigated using nasal endoscopic examination and MRI of the nasopharynx.
After the initial screening, all participants will be phone interviewed yearly to update their cancer status.
A second round of screening will be carried out at 3 to 5 years after the initial round of screening. Subjects will be screened with plasma EBV DNA as in the first round of screening. Subjects with initial positive results will be retested and those with persistently positive results will be investigated using nasal endoscopic examination and MRI of the nasopharynx.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- NPC, Cancer screening, Plasma EBV DNA
- Medical subject headings
- Nasopharyngeal Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis
All the participants will be subjected to the screening of nasopharyngeal carcinoma (NPC) at the time of recruitment using plasma EBV DNA analysis. Subjects with positive results will be investigated using endoscopic examination and MRI. If the subject is confirmed of having NPC, the stage of the disease would be recorded.
Measured: 3 years
Secondary outcomes (2)
Incidence of nasopharyngeal carcinoma in screened negative group
Participants who are screened negative will be followed up yearly for 5 years after the screening. The incidence of NPC will be recorded.
Measured: 5 years
Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results
The relative risk of developing nasopharyngeal carcinoma for subjects with negative, transiently positive and persistently positive plasma Epstein-Barr virus DNA at enrolment will be determined.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2016
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allen Chan, Chinese University of Hong Kong
- Investigators
- Kwan-chee Allen Chan, MD, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063399
- Sponsor's protocol ID
- CU-ChemPath-001
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2014
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chan KC, Hung EC, Woo JK, Chan PK, Leung SF, Lai FP, Cheng AS, Yeung SW, Chan YW, Tsui TK, Kwok JS, King AD, Chan AT, van Hasselt AC, Lo YM. Early detection of nasopharyngeal carcinoma by plasma Epstein-Barr virus DNA analysis in a surveillance program. Cancer. 2013 May 15;119(10):1838-44. doi: 10.1002/cncr.28001. Epub 2013 Feb 21.
PubMed 23436393Lo YM, Chan LY, Lo KW, Leung SF, Zhang J, Chan AT, Lee JC, Hjelm NM, Johnson PJ, Huang DP. Quantitative analysis of cell-free Epstein-Barr virus DNA in plasma of patients with nasopharyngeal carcinoma. Cancer Res. 1999 Mar 15;59(6):1188-91.
PubMed 10096545Chan KCA, Lam WKJ, King A, Lin VS, Lee PPH, Zee BCY, Chan SL, Tse IOL, Tsang AFC, Li MZJ, Jiang P, Ai QYH, Poon DMC, Au KH, Hui EP, Ma BBY, Van Hasselt AC, Chan ATC, Woo JKS, Lo YMD. Plasma Epstein-Barr Virus DNA and Risk of Future Nasopharyngeal Cancer. NEJM Evid. 2023 Jul;2(7):EVIDoa2200309. doi: 10.1056/EVIDoa2200309. Epub 2023 Jun 27.
PubMed 38320164King AD, Ai QYH, Lam WKJ, Tse IOL, So TY, Wong LM, Tsang JYM, Leung HS, Zee BCY, Hui EP, Ma BBY, Vlantis AC, van Hasselt AC, Chan ATC, Woo JKS, Chan KCA. Early detection of nasopharyngeal carcinoma: performance of a short contrast-free screening magnetic resonance imaging. J Natl Cancer Inst. 2024 May 8;116(5):665-672. doi: 10.1093/jnci/djad260.
PubMed 38171488Chan KCA, Woo JKS, King A, Zee BCY, Lam WKJ, Chan SL, Chu SWI, Mak C, Tse IOL, Leung SYM, Chan G, Hui EP, Ma BBY, Chiu RWK, Leung SF, van Hasselt AC, Chan ATC, Lo YMD. Analysis of Plasma Epstein-Barr Virus DNA to Screen for Nasopharyngeal Cancer. N Engl J Med. 2017 Aug 10;377(6):513-522. doi: 10.1056/NEJMoa1701717.
PubMed 28792880
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis
- ClinicalTrials.gov ID
- NCT02063399
- Acronym / sponsor ID
- CU-ChemPath-001
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- NPC, Cancer screening, Plasma EBV DNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20,302 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2030 (estimated)
- First posted
- 14 Feb 2014 (estimated)
- 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 purpose of this study is to determine if the screening of nasopharyngeal carcinoma using plasma Epstein-Barr virus DNA analysis would result in the detecting NPC cases at earlier stages and improve survival.
Detailed description
Epstein-Barr virus (EBV) infection is an important etiological factor for nasopharyngeal carcinoma (NPC). In a pilot study, we have shown that the analysis of Epstein-Barr virus (EBV) DNA in blood can detect early and asymptomatic NPC. However, it is unlcear if NPC screening can improve the prognosis of the screened NPC subjects.
20,000 male subjects aged from 40 to 62 will be recruited because the incidence of NPC is higher in this target group. Twenty millilitres of venous blood will be collected from each subject at enrolment for plasma EBV DNA analysis.
Subjects who have initial positive results for plasma EBV DNA will have another testing at approximately 4 weeks. Subjects who have persistently positive results for the two plasma EBV DNA analyses will be investigated using nasal endoscopic examination and MRI of the nasopharynx.
After the initial screening, all participants will be phone interviewed yearly to update their cancer status.
A second round of screening will be carried out at 3 to 5 years after the initial round of screening. Subjects will be screened with plasma EBV DNA as in the first round of screening. Subjects with initial positive results will be retested and those with persistently positive results will be investigated using nasal endoscopic examination and MRI of the nasopharynx.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 62 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male Hong Kong residents of Chinese ethnicity
Key inclusion criteria (3 listed)
- age 40 to 62 years
- ethnic Chinese
- male
Key exclusion criteria (6 listed)
- history of nasopharyngeal carcinoma
- currently having a malignant disease
- active autoimmune disease
- HIV infection
- on systemic steroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis
Time frame: 3 years
All the participants will be subjected to the screening of nasopharyngeal carcinoma (NPC) at the time of recruitment using plasma EBV DNA analysis. Subjects with positive results will be investigated using endoscopic examination and MRI. If the subject is confirmed of having NPC, the stage of the disease would be recorded.
2 secondary outcomes
Incidence of nasopharyngeal carcinoma in screened negative group
Time frame: 5 years
Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results
Time frame: 5 years
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 27 Oct 2026.
- Background: PubMed 23436393Chan KC, Hung EC, Woo JK, Chan PK, Leung SF, Lai FP, Cheng AS, Yeung SW, Chan YW, Tsui TK, Kwok JS, King AD, Chan AT, van Hasselt AC, Lo YM. Early detection of nasopharyngeal carcinoma by plasma Epstein-Barr virus DNA analysis in a surveillance program. Cancer. 2013 May 15;119(10):1838-44. doi: 10.1002/cncr.28001. Epub 2013 Feb 21.
- Background: PubMed 10096545Lo YM, Chan LY, Lo KW, Leung SF, Zhang J, Chan AT, Lee JC, Hjelm NM, Johnson PJ, Huang DP. Quantitative analysis of cell-free Epstein-Barr virus DNA in plasma of patients with nasopharyngeal carcinoma. Cancer Res. 1999 Mar 15;59(6):1188-91.
- Derived from this study: PubMed 38320164Chan KCA, Lam WKJ, King A, Lin VS, Lee PPH, Zee BCY, Chan SL, Tse IOL, Tsang AFC, Li MZJ, Jiang P, Ai QYH, Poon DMC, Au KH, Hui EP, Ma BBY, Van Hasselt AC, Chan ATC, Woo JKS, Lo YMD. Plasma Epstein-Barr Virus DNA and Risk of Future Nasopharyngeal Cancer. NEJM Evid. 2023 Jul;2(7):EVIDoa2200309. doi: 10.1056/EVIDoa2200309. Epub 2023 Jun 27.
- Derived from this study: PubMed 38171488King AD, Ai QYH, Lam WKJ, Tse IOL, So TY, Wong LM, Tsang JYM, Leung HS, Zee BCY, Hui EP, Ma BBY, Vlantis AC, van Hasselt AC, Chan ATC, Woo JKS, Chan KCA. Early detection of nasopharyngeal carcinoma: performance of a short contrast-free screening magnetic resonance imaging. J Natl Cancer Inst. 2024 May 8;116(5):665-672. doi: 10.1093/jnci/djad260.
- Derived from this study: PubMed 28792880Chan KCA, Woo JKS, King A, Zee BCY, Lam WKJ, Chan SL, Chu SWI, Mak C, Tse IOL, Leung SYM, Chan G, Hui EP, Ma BBY, Chiu RWK, Leung SF, van Hasselt AC, Chan ATC, Lo YMD. Analysis of Plasma Epstein-Barr Virus DNA to Screen for Nasopharyngeal Cancer. N Engl J Med. 2017 Aug 10;377(6):513-522. doi: 10.1056/NEJMoa1701717.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Kwan-chee Allen Chan, MD, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063399, which also lists 5 linked publications.
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 27 Oct 2026.