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

July 6, 2022 updated by: Ming-Yuan Chen, Sun Yat-sen University

Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

11625

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 62 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Residences in Southern China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High risk population of nasopharyngeal carcinoma
first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male
Diagnostic test: EBV antibodies test
ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma
Diagnostic test: EBV DNA test
quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive predictive value
Time Frame: 3 years
the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results
3 years
negative predictive value
Time Frame: 3 years
the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity
Time Frame: 3 years
the percentage of subjects who test positive to those who have nasopharyngeal carcinoma
3 years
specificity
Time Frame: 3 years
the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma
3 years
early diagnose rate
Time Frame: 3 years
the ratio of patients with stage I and stage II disease to all those who have nasopharyngeal carcinoma
3 years
cost-effectiveness
Time Frame: 3 years
the cost of detecting one nasopharyngeal carcinoma case
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Wuzhou Red Cross Hospital
Xiangya Hospital of Central South University
Hunan Cancer Hospital
First People's Hospital of Foshan
Zhongshan People's Hospital, Guangdong, China
The Third Affiliated Hospital of Nanchang University
Yuebei People's Hospital
Changsha Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 10, 2022

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2030

Study Registration Dates

First Submitted

July 2, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-CMY-2022-screen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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