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NCT Number: NCT05447169

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

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

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

30 year–62 year

Sex eligibility

Male

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Ming-Yuan Chen, MD,PhD

CONTACT

[email protected]

86-20-8734-2422

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBV antibodies test

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

Diagnostic Test

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

Primary outcomes

  1. positive predictive value

    Time frame: 3 years

    the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results

  2. 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

Secondary outcomes

  1. sensitivity

    Time frame: 3 years

    the percentage of subjects who test positive to those who have nasopharyngeal carcinoma

  2. specificity

    Time frame: 3 years

    the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma

  3. 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

  4. cost-effectiveness

    Time frame: 3 years

    the cost of detecting one nasopharyngeal carcinoma case

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Yuan Chen, MD, PhD

CONTACT

[email protected]

86-20-8734-3361

Si-Yuan Chen, MD

CONTACT

[email protected]

86-18711150216

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2030
First posted
Jul 7, 2022
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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