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Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

NCT06445088 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 908

Last updated 2024-06-25

No results posted yet for this 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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DIAGNOSTIC_TEST

VCA-IgA, EBNA1-IgA, and EBV-DNA

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

DIAGNOSTIC_TEST

EBV C Promoter Methylation Detection in nasopharyngeal swab samples

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

Sponsors & Collaborators

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Wuzhou Red Cross Hospital

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hai-Qiang Mai · Sun Yat-sen University

  • Zhen-Zhou Xiao · Fujian Cancer Hospital

  • Min-Zhong Tang · Wuzhou Red Cross Hospital

  • Min-Yi Fu · Zhongshan People's Hospital, Guangdong, China

  • Zhe Zhang · First Affiliated Hospital of Guangxi Medical University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445088 on ClinicalTrials.gov