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NCT Number: NCT06445088

Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma DNA Virus Infections Disease Epstein-Barr Virus Infections Head and Neck Neoplasms Herpesviridae Infections Infections Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Tumor Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Cancer Hospital, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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

EBV C Promoter Methylation Detection in nasopharyngeal swab samples

Diagnostic Test

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

Primary outcomes

  1. Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma

    Time frame: From enrollment to final diagnosis, up to 4 weeks

    Measure the sensitivity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Sensitivity will be calculated as the proportion of true positive cases (patients correctly identified with NPC) out of the total number of actual NPC cases.

  2. Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma

    Time frame: From enrollment to final diagnosis, up to 4 weeks

    Measure the specificity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Specificity will be calculated as the proportion of true negative cases (patients correctly identified without NPC) out of the total number of actual non-NPC cases.

  3. Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma

    Time frame: From enrollment to final diagnosis, up to 4 weeks

    Evaluate the agreement between Epstein-Barr Virus (EBV) C Promoter Methylation and the gold standard diagnostic methods for Nasopharyngeal Carcinoma (NPC) using the Kappa statistic. The Kappa value will indicate the consistency and reliability of EBV C Promoter Methylation as a diagnostic tool compared to established diagnostic criteria.

  4. Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection

    Time frame: From enrollment to final diagnosis, up to 4 weeks

    This measure evaluates the positive, negative, and total concordance rates, as well as the Kappa Value, between test reagents and two established sequencing techniques-Sanger sequencing and pyrosequencing-for detecting Epstein-Barr virus C promoter methylation. The accuracy of these detection methods is assessed by comparing their results to those obtained through the widely used and mature technologies of Sanger dideoxy chain termination and pyrosequencing, often considered the "gold standards" for gene sequence analysis. This study aims to evaluate the reliability and accuracy of the test reagents in identifying methylation of the EBV C promoter, using these established sequencing benchmarks.

Secondary outcomes

  1. Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation

    Time frame: From enrollment to final diagnosis, up to 4 weeks

    This outcome measures the agreement rates between EBV C promoter methylation and EBV-related antibodies in the diagnosis of nasopharyngeal carcinoma without a gold standard for comparison. It includes an evaluation of the positive concordance rates, negative concordance rates, and Kappa value, which might reflect limited conclusiveness but offer insight into the relative alignment of these diagnostic tests. This will help ascertain their comparative reliability and diagnostic utility in a real-world setting.

  2. Concordance Rates between EBV-DNA and EBV C Promoter Methylation

    Time frame: From enrollment to final diagnosis, up to 4 weeks

    This outcome measures the agreement rates between EBV C promoter methylation and EBV-DNA in the diagnosis of nasopharyngeal carcinoma without a gold standard for comparison. It includes an evaluation of the positive concordance rates, negative concordance rates, and Kappa value, which might reflect limited conclusiveness but offer insight into the relative alignment of these diagnostic tests. This will help ascertain their comparative reliability and diagnostic utility in a real-world setting.

Other outcomes

  1. Dynamics of EBV C Promoter Methylation Before and After Nasopharyngeal Carcinoma Treatment

    Time frame: From enrollment to the end of treatment at 6 months, up to 1 years

    During follow-up consultations 1 to 6 months post-discharge, nasopharyngeal swabs will be collected to observe the dynamics of EBV C promoter methylation before and after treatment for nasopharyngeal carcinoma

Study contacts

Contact information is provided by the study sponsor or research team.

Hai-Qiang Mai

CONTACT

[email protected]

+86-020-87343380

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • First Affiliated Hospital of Guangxi Medical University
  • Fujian Cancer Hospital
  • Wuzhou Red Cross Hospital
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Official study title

Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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