Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

NCT06445088 | Recruiting

• 1 other identifier: YKP2023-02-04
• Study Type: observational
• Target: 908
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Nasopharyngeal Carcinoma; Diagnosis; Methylation Detection; Epstein-Barr virus

Outcome Measures

Primary Outcomes (4)

• 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.

  From enrollment to final diagnosis, up to 4 weeks

Secondary Outcomes (2)

• Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation

  From enrollment to final diagnosis, up to 4 weeks

• Concordance Rates between EBV-DNA and EBV C Promoter Methylation

  From enrollment to final diagnosis, up to 4 weeks

Other Outcomes (1)

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

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

Study Arms (1)

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; Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples

Interventions

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

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

Diagnosis cohort

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

Diagnosis cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fujian Cancer Hospital: collaborator
• Wuzhou Red Cross Hospital: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator

Study Sites (5)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

ZhongShan City People's Hospital

Zhongshan, Guangdong, 528400, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and nasopharyngeal swabs

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Disease; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Hai-Qiang Mai

  Sun Yat-sen University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Qiang Mai

CONTACT

+86-020-87343380; maihq@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 6, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)