Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
Sun Yat-sen University
908 participants
May 29, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria4
- 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
Interventions
Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.
Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06445088