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NCT06445088Recruiting

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 · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
908 (estimated)
First submitted
27 May 2024
Start date
29 May 2024
Primary completion date
31 Dec 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT06445088

What you commit to

  • Study type: Observational
  • Planned participants: 908
  • From 29 May 2024 to the primary completion date, 31 Dec 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Present any other conditions considered by the investigator as unsuitable for participation in this trial

Other

  • Have been diagnosed with nasopharyngeal carcinoma and have undergone treatment
  • Experience relapse or metastasis of nasopharyngeal carcinoma following treatment
  • Have unsuccessful nasopharyngeal swab collections

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaRecruiting
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The First Affiliated Hospital of Guangxi Medical University
Coordinator of this site? Confirm its status
NanningChinaRecruiting
Wuzhou Red Cross Hospital
Coordinator of this site? Confirm its status
WuzhouChinaRecruiting
Zhongshan City People's Hospital
Coordinator of this site? Confirm its status
ZhongshanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.