Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

June 24, 2024 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

908

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Zhen-Zhou Xiao
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Hai-Qiang Mai
      • Zhongshan, Guangdong, China, 528400
        • Recruiting
        • Zhongshan City People's Hospital
        • Contact:
        • Principal Investigator:
          • Min-Yi Fu
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Principal Investigator:
          • Zhe Zhang
      • Wuzhou, Guangxi, China, 543002
        • Recruiting
        • Wuzhou Red Cross Hospital
        • Principal Investigator:
          • Min-Zhong Tang
        • Contact:
          • Min-Zhong Tang
          • Phone Number: +86-0774-3846519
          • Email: Gxtom@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes individuals suspected of having nasopharyngeal carcinoma or who may be confused with nasopharyngeal carcinoma cases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnosis cohort
The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to final diagnosis, up to 4 weeks
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.
From enrollment to final diagnosis, up to 4 weeks
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.
From enrollment to final diagnosis, up to 4 weeks
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.
From enrollment to final diagnosis, up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to final diagnosis, up to 4 weeks
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.
From enrollment to final diagnosis, up to 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 6 months, up to 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

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

Investigators

  • Study Chair: Hai-Qiang Mai, Sun Yat-sen University
  • Principal Investigator: Zhen-Zhou Xiao, Fujian Cancer Hospital
  • Principal Investigator: Min-Zhong Tang, Wuzhou Red Cross Hospital
  • Principal Investigator: Min-Yi Fu, Zhongshan People's Hospital, Guangdong, China
  • Principal Investigator: Zhe Zhang, First Affiliated Hospital of Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YKP2023-02-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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