Clinical trial NCT06445088: Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
Official title: Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Diagnosis
Methylation Detection
Epstein-Barr virus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fujian Cancer Hospital
name: Wuzhou Red Cross Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: First Affiliated Hospital of Guangxi Medical University
First posted: 2024-06-06
Enrollment: 908
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes individuals suspected of having nasopharyngeal carcinoma or who may be confused with nasopharyngeal carcinoma cases.

Brief 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 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

Primary outcomes:
measure: Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
timeFrame: From enrollment to final diagnosis, up to 4 weeks
measure: Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
timeFrame: From enrollment to final diagnosis, up to 4 weeks
measure: Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
timeFrame: From enrollment to final diagnosis, up to 4 weeks
measure: Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection
timeFrame: From enrollment to final diagnosis, up to 4 weeks
Secondary outcomes:
measure: Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation
timeFrame: From enrollment to final diagnosis, up to 4 weeks
measure: Concordance Rates between EBV-DNA and EBV C Promoter Methylation
timeFrame: From enrollment to final diagnosis, up to 4 weeks
Other outcomes:
measure: Dynamics of EBV C Promoter Methylation Before and After Nasopharyngeal Carcinoma Treatment
timeFrame: From enrollment to the end of treatment at 6 months, up to 1 years
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Zhongshan
country: China
facility: ZhongShan City People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuzhou
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
Study officials:
affiliation: Sun Yat-sen University
name: Hai-Qiang Mai
role: STUDY_CHAIR
affiliation: Fujian Cancer Hospital
name: Zhen-Zhou Xiao
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuzhou Red Cross Hospital
name: Min-Zhong Tang
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan People's Hospital, Guangdong, China
name: Min-Yi Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Zhe Zhang
role: PRINCIPAL_INVESTIGATOR
References: