Nasopharyngeal CarcinomaNCT06445088
Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 5 sites in China.
Trial summary
This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit. All participants will undergo a series of diagnostic tests including VCA-IgA, EBNA1-IgA, and EBV-DNA assays. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- VCA-IgA, EBNA1-IgA, and EBV-DNA and EBV C Promoter Methylation Detection in nasopharyngeal swab samples
- How many people
- 908 participants
- Where
- 5 sitesChina
- Study dates
- 29 May 2024to 31 Dec 2026
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes individuals suspected of having nasopharyngeal carcinoma or who may be confused with nasopharyngeal carcinoma cases.
Who may be able to join
- Participants who meet the following Article 1 and also meet one of Articles 2 to 6 can be enrolled:
- Understand, sign, and date the informed consent document to participate in the study
- Display one or more symptoms or signs indicative of nasopharyngeal carcinoma
- Test positive for EBV antibodies or EBV DNA
- Be diagnosed with other head and neck carcinomas
- Be diagnosed with malignancies associated with EBV infection
- Require differential diagnosis from nasopharyngeal carcinoma during endoscopic or other imaging examinations
- Fulfill any additional conditions deemed appropriate by the investigator for inclusion in this study
Who cannot join
- Have been diagnosed with nasopharyngeal carcinoma and have undergone treatment
- Experience relapse or metastasis of nasopharyngeal carcinoma following treatment
- Have unsuccessful nasopharyngeal swab collections
- Present any other conditions considered by the investigator as unsuitable for participation in this trial
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Zhen-Zhou Xiao, +86-0591-62752500, 1061361859@qq.com
Zhen-Zhou Xiao
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Hai-Qiang Mai, +86-020-87343380, maihq@sysucc.org.cn
Hai-Qiang Mai
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhe Zhang, +86-0771-5309187, Zhangzhe1975@hotmail.com
Zhe Zhang
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, 543002
Min-Zhong Tang, +86-0774-3846519, Gxtom@163.com
Min-Zhong Tang
- Recruiting
ZhongShan City People's Hospital
Zhongshan, Guangdong, 528400
Min-Yi Fu, +86-0760-89880340, Mininefu@tom.com
Min-Yi Fu
About this study
Official title: Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit. All participants will undergo a series of diagnostic tests including VCA-IgA, EBNA1-IgA, and EBV-DNA assays. Additionally, nasopharyngeal swabs will be analyzed for EBV C promoter methylation. Confirmatory biopsy will be performed on all patients to establish a definitive diagnosis. This comprehensive approach seeks to assess the effectiveness of the methylation detection kit in a clinical setting.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- VCA-IgA, EBNA1-IgA, and EBV-DNA, EBV C Promoter Methylation Detection in nasopharyngeal swab samples
- Keywords
- Nasopharyngeal Carcinoma, Diagnosis, Methylation Detection, Epstein-Barr virus
- Medical subject headings
- Nasopharyngeal Carcinoma, Disease, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCA-IgA, EBNA1-IgA, and EBV-DNADiagnostic test
Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.
EBV C Promoter Methylation Detection in nasopharyngeal swab samplesDiagnostic test
Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis cohort | The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma Receives: Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNA; Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Measure the sensitivity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Sensitivity will be calculated as the proportion of true positive cases (patients correctly identified with NPC) out of the total number of actual NPC cases.
Measured: From enrollment to final diagnosis, up to 4 weeks
Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Measure the specificity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Specificity will be calculated as the proportion of true negative cases (patients correctly identified without NPC) out of the total number of actual non-NPC cases.
Measured: From enrollment to final diagnosis, up to 4 weeks
Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Evaluate the agreement between Epstein-Barr Virus (EBV) C Promoter Methylation and the gold standard diagnostic methods for Nasopharyngeal Carcinoma (NPC) using the Kappa statistic. The Kappa value will indicate the consistency and reliability of EBV C Promoter Methylation as a diagnostic tool compared to established diagnostic criteria.
Measured: From enrollment to final diagnosis, up to 4 weeks
Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection
This measure evaluates the positive, negative, and total concordance rates, as well as the Kappa Value, between test reagents and two established sequencing techniques-Sanger sequencing and pyrosequencing-for detecting Epstein-Barr virus C promoter methylation. The accuracy of these detection methods is assessed by comparing their results to those obtained through the widely used and mature technologies of Sanger dideoxy chain termination and pyrosequencing, often considered the "gold standards" for gene sequence analysis. This study aims to evaluate the reliability and accuracy of the test reagents in identifying methylation of the EBV C promoter, using these established sequencing benchmarks.
Measured: From enrollment to final diagnosis, up to 4 weeks
Secondary outcomes (2)
Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation
This outcome measures the agreement rates between EBV C promoter methylation and EBV-related antibodies in the diagnosis of nasopharyngeal carcinoma without a gold standard for comparison. It includes an evaluation of the positive concordance rates, negative concordance rates, and Kappa value, which might reflect limited conclusiveness but offer insight into the relative alignment of these diagnostic tests. This will help ascertain their comparative reliability and diagnostic utility in a real-world setting.
Measured: From enrollment to final diagnosis, up to 4 weeks
Concordance Rates between EBV-DNA and EBV C Promoter Methylation
This outcome measures the agreement rates between EBV C promoter methylation and EBV-DNA in the diagnosis of nasopharyngeal carcinoma without a gold standard for comparison. It includes an evaluation of the positive concordance rates, negative concordance rates, and Kappa value, which might reflect limited conclusiveness but offer insight into the relative alignment of these diagnostic tests. This will help ascertain their comparative reliability and diagnostic utility in a real-world setting.
Measured: From enrollment to final diagnosis, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start29 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 908 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
- Investigators
- Hai-Qiang Mai, Study chair, Sun Yat-sen UniversityZhen-Zhou Xiao, Principal investigator, Fujian Cancer HospitalMin-Zhong Tang, Principal investigator, Wuzhou Red Cross HospitalMin-Yi Fu, Principal investigator, Zhongshan People's Hospital, Guangdong, ChinaZhe Zhang, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445088
- Sponsor's protocol ID
- YKP2023-02-04
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06445088
- Acronym / sponsor ID
- YKP2023-02-04
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Diagnosis, Methylation Detection, Epstein-Barr virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 908 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China, First Affiliated Hospital of Guangxi Medical University
- Study start
- 29 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jun 2024 (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.
This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit. All participants will undergo a series of diagnostic tests including VCA-IgA, EBNA1-IgA, and EBV-DNA assays. Additionally, nasopharyngeal swabs will be analyzed for EBV C promoter methylation. Confirmatory biopsy will be performed on all patients to establish a definitive diagnosis. This comprehensive approach seeks to assess the effectiveness of the methylation detection kit in a clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis cohort | – | Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNA, Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samplesThe participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes individuals suspected of having nasopharyngeal carcinoma or who may be confused with nasopharyngeal carcinoma cases.
Key inclusion criteria (8 listed)
- Participants who meet the following Article 1 and also meet one of Articles 2 to 6 can be enrolled:
- Understand, sign, and date the informed consent document to participate in the study
- Display one or more symptoms or signs indicative of nasopharyngeal carcinoma
- Test positive for EBV antibodies or EBV DNA
- Be diagnosed with other head and neck carcinomas
Key exclusion criteria (4 listed)
- Have been diagnosed with nasopharyngeal carcinoma and have undergone treatment
- Experience relapse or metastasis of nasopharyngeal carcinoma following treatment
- Have unsuccessful nasopharyngeal swab collections
- Present any other conditions considered by the investigator as unsuitable for participation in this trial
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 |
|---|---|---|
| VCA-IgA, EBNA1-IgA, and EBV-DNADetect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants. | Diagnostic test | Diagnosis cohort |
| EBV C Promoter Methylation Detection in nasopharyngeal swab samplesDetection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples | Diagnostic test | Diagnosis cohort |
Primary outcome
Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Time frame: From enrollment to final diagnosis, up to 4 weeks
Measure the sensitivity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Sensitivity will be calculated as the proportion of true positive cases (patients correctly identified with NPC) out of the total number of actual NPC cases.
Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Time frame: From enrollment to final diagnosis, up to 4 weeks
Measure the specificity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Specificity will be calculated as the proportion of true negative cases (patients correctly identified without NPC) out of the total number of actual non-NPC cases.
Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Time frame: From enrollment to final diagnosis, up to 4 weeks
Evaluate the agreement between Epstein-Barr Virus (EBV) C Promoter Methylation and the gold standard diagnostic methods for Nasopharyngeal Carcinoma (NPC) using the Kappa statistic. The Kappa value will indicate the consistency and reliability of EBV C Promoter Methylation as a diagnostic tool compared to established diagnostic criteria.
Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection
Time frame: From enrollment to final diagnosis, up to 4 weeks
This measure evaluates the positive, negative, and total concordance rates, as well as the Kappa Value, between test reagents and two established sequencing techniques-Sanger sequencing and pyrosequencing-for detecting Epstein-Barr virus C promoter methylation. The accuracy of these detection methods is assessed by comparing their results to those obtained through the widely used and mature technologies of Sanger dideoxy chain termination and pyrosequencing, often considered the "gold standards" for gene sequence analysis. This study aims to evaluate the reliability and accuracy of the test reagents in identifying methylation of the EBV C promoter, using these established sequencing benchmarks.
2 secondary outcomes
Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation
Time frame: From enrollment to final diagnosis, up to 4 weeks
Concordance Rates between EBV-DNA and EBV C Promoter Methylation
Time frame: From enrollment to final diagnosis, up to 4 weeks
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 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Hai-Qiang Mai study chair
Sun Yat-sen University
Zhen-Zhou Xiao principal investigator
Fujian Cancer Hospital
Min-Zhong Tang principal investigator
Wuzhou Red Cross Hospital
5 sites 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 5 sites 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 8 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: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Hai-Qiang Mai (+86-020-87343380, maihq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma (time frame: From enrollment to final diagnosis, up to 4 weeks). The study lists 4 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 25 Jun 2024.