Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VCA-IgA, EBNA1-IgA, and EBV-DNA, EBV C Promoter Methylation Detection in nasopharyngeal swab samples.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
Overview
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.
Interventions
- Diagnostic test VCA-IgA, EBNA1-IgA, and EBV-DNA
Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants. - Diagnostic test EBV C Promoter Methylation Detection in nasopharyngeal swab samples
Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples
Primary outcome measures
- Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma [Time frame: From enrollment to final diagnosis, up to 4 weeks]
- Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma [Time frame: From enrollment to final diagnosis, up to 4 weeks]
- Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma [Time frame: From enrollment to final diagnosis, up to 4 weeks]
- 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]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- Fujian Cancer Hospital — Fuzhou
- Sun Yat-Sen University Cancer Center — Guangzhou
- ZhongShan City People's Hospital — Zhongshan
- The First Affiliated Hospital of Guangxi Medical University — Nanning
- Wuzhou Red Cross Hospital — Wuzhou
Identifiers
NCT: NCT06445088 · YKP2023-02-04