Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 908
- 试验地点
- 5
- 主要终点
- Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
时间窗: 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
时间窗: 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.
Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection
时间窗: 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.
Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
时间窗: 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.
次要结局
- Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation(From enrollment to final diagnosis, up to 4 weeks)
- Concordance Rates between EBV-DNA and EBV C Promoter Methylation(From enrollment to final diagnosis, up to 4 weeks)
研究者
Hai-Qiang Mai,MD,PhD
Principal Investigator
Sun Yat-sen University