RecruitingNCT06445088

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


Sponsor

Sun Yat-sen University

Enrollment

908 participants

Start Date

May 29, 2024

Study Type

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

Plain Language Summary

Simplified for easier understanding

This study is evaluating the accuracy of a lab test that detects a specific type of DNA change (EBV C promoter methylation) in nasopharyngeal swab samples to diagnose nasopharyngeal carcinoma — a cancer in the back of the nose and throat associated with the Epstein-Barr virus (EBV). **You may be eligible if...** - You have one or more symptoms suggesting nasopharyngeal carcinoma - You have tested positive for EBV antibodies or EBV DNA - You have been diagnosed with another head and neck cancer or an EBV-related cancer - You need a test to rule out nasopharyngeal carcinoma during an endoscopy or imaging - You are able to give informed consent **You may NOT be eligible if...** - You have already been diagnosed and treated for nasopharyngeal carcinoma - Your nasopharyngeal carcinoma has relapsed or spread after treatment - A successful swab sample could not be collected Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTVCA-IgA, EBNA1-IgA, and EBV-DNA

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

DIAGNOSTIC_TESTEBV C Promoter Methylation Detection in nasopharyngeal swab samples

Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples


Locations(5)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

ZhongShan City People's Hospital

Zhongshan, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

View Full Details on ClinicalTrials.gov

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NCT06445088


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