Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

NCT ID: NCT06445088

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-29

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnosis cohort

The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma

VCA-IgA, EBNA1-IgA, and EBV-DNA

Intervention Type DIAGNOSTIC_TEST

Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.

EBV C Promoter Methylation Detection in nasopharyngeal swab samples

Intervention Type DIAGNOSTIC_TEST

Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples

Interventions

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VCA-IgA, EBNA1-IgA, and EBV-DNA

Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.

Intervention Type DIAGNOSTIC_TEST

EBV C Promoter Methylation Detection in nasopharyngeal swab samples

Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Wuzhou Red Cross Hospital

OTHER

Sponsor Role collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Hai-Qiang Mai,MD,PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hai-Qiang Mai

Role: STUDY_CHAIR

Sun Yat-sen University

Zhen-Zhou Xiao

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Min-Zhong Tang

Role: PRINCIPAL_INVESTIGATOR

Wuzhou Red Cross Hospital

Min-Yi Fu

Role: PRINCIPAL_INVESTIGATOR

Zhongshan People's Hospital, Guangdong, China

Zhe Zhang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Guangxi Medical University

Locations

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Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

ZhongShan City People's Hospital

Zhongshan, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hai-Qiang Mai

Role: CONTACT

+86-020-87343380

Facility Contacts

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Zhen-Zhou Xiao

Role: primary

+86-0591-62752500

Hai-Qiang Mai

Role: primary

+86-020-87343380

Min-Yi Fu

Role: primary

+86-0760-89880340

Zhe Zhang

Role: primary

+86-0771-5309187

Min-Zhong Tang

Role: primary

+86-0774-3846519

Other Identifiers

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YKP2023-02-04

Identifier Type: -

Identifier Source: org_study_id

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