NCT06445088 Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
| NCT ID | NCT06445088 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 908 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 908 participants in total. It began in 2024-05-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hai-Qiang Mai
STUDY CHAIR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT06445088 clinical trial?
This trial is open to participants of all sexes, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06445088 currently recruiting?
Yes, NCT06445088 is actively recruiting participants. Contact the research team at maihq@sysucc.org.cn for enrollment information.
Where is the NCT06445088 trial being conducted?
This trial is being conducted at Fuzhou, China, Guangzhou, China, Zhongshan, China, Nanning, China and 1 additional location.
Who is sponsoring the NCT06445088 clinical trial?
NCT06445088 is sponsored by Sun Yat-sen University. The principal investigator is Hai-Qiang Mai at Sun Yat-sen University. The trial plans to enroll 908 participants.