Evaluating a new test for diagnosing nasopharyngeal carcinoma
Official title: Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
Run by Sun Yat-sen University · NCT06445088 · Data updated 2026-11-12
This study is testing a new kit that checks for a specific virus in patients to see if it can help doctors better diagnose nasopharyngeal carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 908 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 5 sites (Fuzhou, Fujian and 4 other locations) |
| Status | Recruiting |
| Started | May 29, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 25, 2024 |
| Trial ID | NCT06445088 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals displaying symptoms of nasopharyngeal carcinoma and testing positive for EBV antibodies or DNA.
✕Probably not a fit
Patients who have already been diagnosed with nasopharyngeal carcinoma and have undergone treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study assesses the diagnostic performance of a novel Epstein-Barr virus (EBV) C promoter methylation detection kit for nasopharyngeal carcinoma. Participants will undergo various diagnostic tests, including VCA-IgA, EBNA1-IgA, and EBV-DNA assays, along with nasopharyngeal swabs to analyze EBV C promoter methylation. A confirmatory biopsy will be performed on all patients to establish a definitive diagnosis, aiming to evaluate the kit's effectiveness in a clinical setting.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing nasopharyngeal carcinoma, leading to earlier and more effective treatment options for patients.
How similar studies have gone: While the approach of using methylation detection for diagnosis is promising, the specific application of this kit in nasopharyngeal carcinoma is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fujian Cancer Hospital
Fuzhou, Fujian, China Recruiting -
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China Recruiting -
ZhongShan City People's Hospital
Zhongshan, Guangdong, China Recruiting -
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China Recruiting -
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China Recruiting
Study contacts
- Principal investigator: Zhen-Zhou Xiao — Fujian Cancer Hospital
- Study coordinator: Hai-Qiang Mai
- Email: maihq@sysucc.org.cn
- Phone: +86-020-87343380
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.