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| Name | Class |
|---|---|
| Fujian Cancer Hospital | OTHER_GOV |
| Wuzhou Red Cross Hospital | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| First Affiliated Hospital of Guangxi Medical University |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosis cohort | The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCA-IgA, EBNA1-IgA, and EBV-DNA | Diagnostic Test | Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Participants who meet the following Article 1 and also meet one of Articles 2 to 6 can be enrolled:
Exclusion Criteria:
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The study population includes individuals suspected of having nasopharyngeal carcinoma or who may be confused with nasopharyngeal carcinoma cases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Qiang Mai | Contact | +86-020-87343380 | maihq@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hai-Qiang Mai | Sun Yat-sen University | Study Chair |
| Zhen-Zhou Xiao | Fujian Cancer Hospital | Principal Investigator |
| Min-Zhong Tang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D004194 | Disease |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
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Blood and nasopharyngeal swabs
| 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 |
|
| From enrollment to final diagnosis, up to 4 weeks |
| From enrollment to final diagnosis, up to 4 weeks |
| 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 |
| 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 | Principal Investigator |
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| ZhongShan City People's Hospital | Recruiting | Zhongshan | Guangdong | 528400 | China |
|
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
|
| Wuzhou Red Cross Hospital | Recruiting | Wuzhou | Guangxi | 543002 | China |
|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |