Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNADiagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples
- Registration Number
- NCT06445088
- Lead Sponsor
- Sun Yat-sen University
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 908
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diagnosis cohort VCA-IgA, EBNA1-IgA, and EBV-DNA The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma Diagnosis cohort EBV C Promoter Methylation Detection in nasopharyngeal swab samples The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma
- Primary Outcome Measures
Name Time Method Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation From enrollment to final diagnosis, up to 4 weeks 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.
Concordance Rates between EBV-DNA and EBV C Promoter Methylation From enrollment to final diagnosis, up to 4 weeks 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.
Trial Locations
- Locations (5)
Wuzhou Red Cross Hospital
🇨🇳Wuzhou, Guangxi, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
ZhongShan City People's Hospital
🇨🇳Zhongshan, Guangdong, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China