Nasopharyngeal CarcinomaNCT05447169
Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 30 to 62 years, men only
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- EBV antibodies test and EBV DNA test
- How many people
- 11,625 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2022to 1 Jul 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 30 to 62 years
- Men only
- Adult
Study population: Residences in Southern China
Who may be able to join
- residents in Southern China
- 30-62 years old
- male
- a first-degree relative of at least one nasopharyngeal carcinoma patient
- no medical record of nasopharyngeal carcinoma
- Eastern Cooperative Oncology Group score of 0-2
- be able to comprehend, sign, and date the written informed consent document to participate in the study
Who cannot join
- history of nasopharyngeal carcinoma
- heavy cardiovascular, liver or kidney disease
- on systemic steroid or immunosuppressant treatment or active autoimmune disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD,PhD, 86-20-8734-2422, chmingy@mail.sysu.edu.cn
About this study
Official title: Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population
The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.
Read the detailed description
The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- EBV antibodies test, EBV DNA test
- Keywords
- Nasopharyngeal Carcinoma Screen, EBV DNA, EBV antibody
- 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 antibodies testDiagnostic test
ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma
EBV DNA testDiagnostic test
quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma
| Study group | Role | What they receive |
|---|---|---|
| High risk population of nasopharyngeal carcinoma | first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male Receives: Diagnostic Test: EBV antibodies test; Diagnostic Test: EBV DNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive predictive value
the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results
Measured: 3 years
negative predictive value
the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results
Measured: 3 years
Secondary outcomes (4)
sensitivity
the percentage of subjects who test positive to those who have nasopharyngeal carcinoma
Measured: 3 years
specificity
the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma
Measured: 3 years
early diagnose rate
the ratio of patients with stage I and stage II disease to all those who have nasopharyngeal carcinoma
Measured: 3 years
cost-effectiveness
the cost of detecting one nasopharyngeal carcinoma case
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start10 Jul 2022 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2030 (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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 11,625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China, Hunan Cancer Hospital, The Third Affiliated Hospital of Nanchang University, First People's Hospital of Foshan, Yuebei People's Hospital, Xiangya Hospital of Central South University, Changsha Central Hospital
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD, PhD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447169
- Sponsor's protocol ID
- SYSUCC-CMY-2022-screen
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population
- ClinicalTrials.gov ID
- NCT05447169
- Acronym / sponsor ID
- SYSUCC-CMY-2022-screen
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma Screen, EBV DNA, EBV antibody
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,625 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China, Hunan Cancer Hospital, The Third Affiliated Hospital of Nanchang University, First People's Hospital of Foshan, Yuebei People's Hospital, Xiangya Hospital of Central South University, Changsha Central Hospital
- Study start
- 10 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 7 Jul 2022 (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 investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.
Detailed description
The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk population of nasopharyngeal carcinoma | – | Diagnostic Test: EBV antibodies test, Diagnostic Test: EBV DNA testfirst-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male |
Who may qualify
- Ages
- 30 to 62 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Residences in Southern China
Key inclusion criteria (7 listed)
- residents in Southern China
- 30-62 years old
- male
- a first-degree relative of at least one nasopharyngeal carcinoma patient
- no medical record of nasopharyngeal carcinoma
Key exclusion criteria (3 listed)
- history of nasopharyngeal carcinoma
- heavy cardiovascular, liver or kidney disease
- on systemic steroid or immunosuppressant treatment or active autoimmune 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 |
|---|---|---|
| EBV antibodies testELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma | Diagnostic test | High risk population of nasopharyngeal carcinoma |
| EBV DNA testquantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma | Diagnostic test | High risk population of nasopharyngeal carcinoma |
Primary outcome
positive predictive value
Time frame: 3 years
the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results
negative predictive value
Time frame: 3 years
the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results
4 secondary outcomes
sensitivity
Time frame: 3 years
specificity
Time frame: 3 years
early diagnose rate
Time frame: 3 years
cost-effectiveness
Time frame: 3 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 8 Jul 2022.
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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.
Ming-Yuan Chen, MD, PhD study chair
Sun Yat-sen University
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 7 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 8 Jul 2022. 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?
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 Ming-Yuan Chen, MD, PhD (86-20-8734-3361, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive predictive value (time frame: 3 years). The study lists 2 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 8 Jul 2022.