Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma

Treatments: Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNA; Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples

Study type: Observational

Funder types: Other

Identifiers

NCT06445088

YKP2023-02-04

Details and patient eligibility

About

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.

Enrollment: 908 estimated patients

Sex: All

Volunteers: No 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

Trial design

908 participants in 1 patient group

Diagnosis cohort

Description:

The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma

Treatment:

Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples

Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNA