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Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

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Phase N/A

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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.

Eligibility

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

Study details
    Nasopharyngeal Carcinoma

NCT06445088

Sun Yat-sen University

17 June 2024

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FAQs

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