Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening

NCT ID: NCT05447169

Last Updated: 2022-07-08

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

11625 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-10

Study Completion Date

2030-07-01

Brief Summary

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The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.

Detailed Description

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The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A, Epstein-Barr nuclear antigen 1-immunoglobulin A, early antigen-immunoglobulin A, Zta-immunoglobulin A, Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk population of nasopharyngeal carcinoma

first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male

EBV antibodies test

Intervention Type DIAGNOSTIC_TEST

ELISA test of VCA-IgA,EBNA1-IgA,EA-IgA, Zta-IgA ,Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma

EBV DNA test

Intervention Type DIAGNOSTIC_TEST

quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

Interventions

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EBV antibodies test

ELISA test of VCA-IgA,EBNA1-IgA,EA-IgA, Zta-IgA ,Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma

Intervention Type DIAGNOSTIC_TEST

EBV DNA test

quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* residents in Southern China
* 30-62 years old
* male
* a first-degree relative of at least one nasopharyngeal carcinoma patient
* no medical record of nasopharyngeal carcinoma
* Eastern Cooperative Oncology Group score of 0-2
* be able to comprehend, sign, and date the written informed consent document to participate in the study

Exclusion Criteria

* history of nasopharyngeal carcinoma
* heavy cardiovascular, liver or kidney disease
* on systemic steroid or immunosuppressant treatment or active autoimmune disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

62 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wuzhou Red Cross Hospital

OTHER

Sponsor Role collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role collaborator

Yuebei People's Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Changsha Central Hospital

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ming-Yuan Chen

professor & chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming-Yuan Chen, MD, PhD

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

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Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming-Yuan Chen, MD, PhD

Role: CONTACT

86-20-8734-3361

Si-Yuan Chen, MD

Role: CONTACT

86-18711150216

Facility Contacts

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Ming-Yuan Chen, MD,PhD

Role: primary

86-20-8734-2422

Other Identifiers

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SYSUCC-CMY-2022-screen

Identifier Type: -

Identifier Source: org_study_id

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