Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Wuzhou Red Cross Hospital
RECRUITING
Wuzhou
ZhongShan City People's Hospital
RECRUITING
Zhongshan
Contact Information
Primary
Hai-Qiang Mai
maihq@sysucc.org.cn
+86-020-87343380
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 908
Treatments
Diagnosis cohort
The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma
Related Therapeutic Areas
Sponsors
Collaborators: Wuzhou Red Cross Hospital, Fujian Cancer Hospital, Zhongshan People's Hospital, Guangdong, China, First Affiliated Hospital of Guangxi Medical University
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov