Clinical trial · Observational
Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBV C Promoter Methylation Detection in nasopharyngeal swab samples | Diagnostic Test | — | UNRESOLVED |
| VCA-IgA, EBNA1-IgA, and EBV-DNA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnosis cohort
- description
- The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma
- interventionNames
- Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNA
- Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples
Primary outcomes (4)
- measure
- Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
- timeFrame
- From enrollment to final diagnosis, up to 4 weeks
- description
- 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.
- measure
- Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available