Clinical trial Recruiting at 5 sites Observational

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 typeObservational
SexAll
Enrollment908 (estimated)
SponsorSun Yat-sen University
Academic / other
Locations5 sites (Fuzhou, Fujian and 4 other locations)
StatusRecruiting
StartedMay 29, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 25, 2024
Trial IDNCT06445088 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.