Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445088
• Other study ID #: YKP2023-02-04
• Status: Recruiting
• Start date: May 29, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Sun Yat-sen University
• Contact: Hai-Qiang Mai
• Phone: +86-020-87343380
• Email: maihq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 908
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Diagnostic Test:
• VCA-IgA, EBNA1-IgA, and EBV-DNA
Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.
• EBV C Promoter Methylation Detection in nasopharyngeal swab samples
Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Wuzhou Red Cross Hospital	Wuzhou	Guangxi
China	ZhongShan City People's Hospital	Zhongshan	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital of Guangxi Medical University, Fujian Cancer Hospital, Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dynamics of EBV C Promoter Methylation Before and After Nasopharyngeal Carcinoma Treatment	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
Primary	Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma	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
Primary	Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma	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
Primary	Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma	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
Primary	Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection	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	Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation	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
Secondary	Concordance Rates between EBV-DNA and EBV C Promoter Methylation	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