Evaluating a new test for diagnosing nasopharyngeal carcinoma
Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
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 |
|---|---|
| Enrollment | 908 (estimated) |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 5 sites (Fuzhou, Fujian and 4 other locations) |
| Trial ID | NCT06445088 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals displaying symptoms of nasopharyngeal carcinoma and testing positive for EBV antibodies or DNA.
Not a fit: Patients who have already been diagnosed with nasopharyngeal carcinoma and have undergone treatment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Fuzhou, Fujian and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.