Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

NCT06445088 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Observational

Started

2024-05-29

Last updated

2024-06-25

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

VCA-IgA, EBNA1-IgA, and EBV-DNAEBV C Promoter Methylation Detection in nasopharyngeal swab samples

VCA-IgA, EBNA1-IgA, and EBV-DNA: Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.

EBV C Promoter Methylation Detection in nasopharyngeal swab samples: Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.
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.
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.

Trial sites (5)

Facility	City	Region	Status
Fujian Cancer Hospital	Fuzhou	Fujian	Recruiting
Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong	Recruiting
ZhongShan City People's Hospital	Zhongshan	Guangdong	Recruiting
The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	Recruiting
Wuzhou Red Cross Hospital	Wuzhou	Guangxi	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06445088 on ClinicalTrials.gov ↗ ← All trials in China