Nasopharyngeal CarcinomaNCT03855020
Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Plasma EBV DNA
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2019to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed, non-metastatic, previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
- No evidence of distant metastasis (M0)
- Receive standard radical treatment
- Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained
Who cannot join
- WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Severe intercurrent disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Plasma EBV DNA
- Keywords
- plasma EBV DNA, nasopharyngeal carcinoma, longitudinal surveillance
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma EBV DNADiagnostic test
Parameters analyzed will include (1) the changing pattern of plasma EBV DNA concentrations during chemotherapy and radiotherapy (2) half-life values (t1/2) of plasma EBV DNA clearance rate
| Study group | Role | What they receive |
|---|---|---|
| observational cohort | Patients enrolled in this observational cohort would have regular blood taking for EBV DNA examination at baseline, after every cycle of chemotherapy, every week during radiotherapy, and 1-3 months after chemo-radiotherapy until EBV DNA becomes undetectable for at least two times. Receives: Diagnostic Test: Plasma EBV DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.
Measured: 3 years
Secondary outcomes (4)
overall survival
Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
Measured: 3 years
Distant metastasis-free survival
Distant metastasis-free survival is calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
Measured: 3 years
locoregional failure-free survival
Local or regional failure-free survival is calculated from the date of diagnosis of NPC to the date of regional nodal failure or date of death from any cause, whichever comes earlier.
Measured: 3 years
EBV DNA clearance rate
The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of [t1/2 = 0.693/k].
Measured: during the first month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start9 May 2019
- Primary completion10 May 2022
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Sun Yat-sen UniversityThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Sun, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855020
- Sponsor's protocol ID
- 2019-FXY-015-radiation
- Status last verified
- Jun 2023
- First submitted
- 21 Feb 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not to share individual participant data (IPD) available to other researchers unless reasonably required, and only the PI has the whole access to the complete data
Publications
Lv J, Zheng DX, Liang JH, Zhang N, Ye ZL, Xu XD, Chua MLK, Zhang LL, Du ZM, Zhang ZC, Li WF, Tang LL, Chen L, Mao YP, Guo R, Chen YP, Lin L, Zhang Y, Liu X, Xu C, Li ZX, Xu LX, Yang PY, Chen K, Bin D, Gao TS, Yan JY, Chen LS, Huang SH, Zhao HY, Hong SB, Jie YS, Huang HL, Tang XH, Yun JP, Liu LZ, Tian L, Li HJ, Li JB, Zhou GQ, Ma J, Sun Y. Risk-adaptive therapy guided by dynamic ctDNA in nasopharyngeal carcinoma. Nature. 2026 Apr;652(8110):731-739. doi: 10.1038/s41586-026-10244-w. Epub 2026 Mar 11.
PubMed 41813900
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
- ClinicalTrials.gov ID
- NCT03855020
- Acronym / sponsor ID
- 2019-FXY-015-radiation
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- plasma EBV DNA, nasopharyngeal carcinoma, longitudinal surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 26 Feb 2019 (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.
Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational cohort | – | Diagnostic Test: Plasma EBV DNAPatients enrolled in this observational cohort would have regular blood taking for EBV DNA examination at baseline, after every cycle of chemotherapy, every week during radiotherapy, and 1-3 months after chemo-radiotherapy until EBV DNA becomes undetectable for at least two times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed, non-metastatic, previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.
Key inclusion criteria (4 listed)
- Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
- No evidence of distant metastasis (M0)
- Receive standard radical treatment
- Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained
Key exclusion criteria (4 listed)
- WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Severe intercurrent disease
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 |
|---|---|---|
| Plasma EBV DNAParameters analyzed will include (1) the changing pattern of plasma EBV DNA concentrations during chemotherapy and radiotherapy (2) half-life values (t1/2) of plasma EBV DNA clearance rate | Diagnostic test | observational cohort |
Primary outcome
Progression-free survival
Time frame: 3 years
Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.
4 secondary outcomes
overall survival
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
locoregional failure-free survival
Time frame: 3 years
EBV DNA clearance rate
Time frame: during the first month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 41813900Lv J, Zheng DX, Liang JH, Zhang N, Ye ZL, Xu XD, Chua MLK, Zhang LL, Du ZM, Zhang ZC, Li WF, Tang LL, Chen L, Mao YP, Guo R, Chen YP, Lin L, Zhang Y, Liu X, Xu C, Li ZX, Xu LX, Yang PY, Chen K, Bin D, Gao TS, Yan JY, Chen LS, Huang SH, Zhao HY, Hong SB, Jie YS, Huang HL, Tang XH, Yun JP, Liu LZ, Tian L, Li HJ, Li JB, Zhou GQ, Ma J, Sun Y. Risk-adaptive therapy guided by dynamic ctDNA in nasopharyngeal carcinoma. Nature. 2026 Apr;652(8110):731-739. doi: 10.1038/s41586-026-10244-w. Epub 2026 Mar 11.
- Individual participant dataSharing planned: No. not to share individual participant data (IPD) available to other researchers unless reasonably required, and only the PI has the whole access to the complete data
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sun Yat-sen University at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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 China. 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?
Results are not available in the source record.
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?
Progression-free survival (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 NCT03855020, which also lists 1 linked publication.
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 18 Jun 2023.