Comparison and Strategy Optimization of Plasma EBV DNA and P85-Ab with VCA/EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas

NCT06870435 | Recruiting DMC

• 1 other identifier: ZDWY.BYAFZZX.032
• Study Type: interventional
• Target: 68,649
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, self-controlled, multicenter clinical trial. All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored. First, it aims to investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening, thereby identifying the optimal initial NPC screening strategy. Based on the determined optimal initial screening strategy, the study will validate the proposed two-step method (subjects first undergo two-antibody method testing and P85-Ab testing; those positive for either one biomarker above proceed to plasma EBV DNA testing; subjects positive in both steps are defined as high-risk and receive endoscopic examinations with or without biopsy) compared with the single-step method (subjects simultaneously undergo two-antibody method testing, P85-Ab testing, and plasma EBV DNA testing; subjects with any positive biomarker undergo endoscopic examinations with or without biopsy) and each single screening testing. The aim is to determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity, thereby enhancing screening efficiency, reducing the rate of invasive procedures (such as endoscopic biopsies), and lowering medical costs and insurance burdens.

Conditions

Nasopharyngeal Carcinoma (NPC); Screening; Epstein Barr Virus

Keywords

Nasopharyngeal Carcinoma (NPC); Screening; Epstein Barr Virus; EBV DNA; EBV antibody

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing

  To investigate whether plasma EBV DNA testing or the P85-Ab testing can achieve higher sensitivity than the current standard two-antibody method testing while maintaining specificity in NPC screening. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.

  At screening, 3 years and 10 years thereafter.

• Sensitivity and positive predictive value (PPV) of the two-step method, single-step method and each single screening testing.

  To determine whether two-step method can further improve the positive predictive value (PPV) while maintaining non-inferior sensitivity. PPV refers to the proportion of positive test results that are true positives. Sensitivity refers to the proportion of actual positive cases (true positives) correctly identified by a test.

  At screening, 3 years and 10 years thereafter.

Secondary Outcomes (5)

• Negative predictive value (NPV)

  At screening, 3 years and 10 years thereafter.

• Early diagnosis rate of nasopharyngeal carcinoma

  At screening, 3 years and 10 years thereafter.

• Number needed to screen (NNS)

  At screening, 3 years and 10 years thereafter.

• Nasopharyngeal Carcinoma Death Rates

  At screening, 3 years and 10 years thereafter.

• Death Rates From All Causes

  At screening, 3 years and 10 years thereafter.

Study Arms (1)

Screening cohort

EXPERIMENTAL

Participants aged between 30 and 69 years old.

Biological: Blood, nasopharyngeal swab and saliva; Diagnostic Test: EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA; Diagnostic Test: Novel screening biomarkers; Diagnostic Test: Endoscopic examinations with or without biopsy

Interventions

Blood, nasopharyngeal swab and saliva BIOLOGICAL

Collect blood, nasopharyngeal swab and saliva samples from participants.

Screening cohort

EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA DIAGNOSTIC_TEST

Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants.

Screening cohort

Novel screening biomarkers DIAGNOSTIC_TEST

Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc..

Screening cohort

Endoscopic examinations with or without biopsy DIAGNOSTIC_TEST

High-risk participants will refer to endoscopic examinations with or without biopsy

Screening cohort

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent.
• Age between 30 and 69 years at the time of screening.
• Residents of Guangdong Province or Guangxi Province.
• Able to cooperate with long-term follow-up.

You may not qualify if:

• Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders.
• Severe autoimmune diseases or immunodeficiency.
• History of or current malignant tumors.
• Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.

Sponsors & Collaborators

• Ming-Yuan Chen: lead

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Epstein-Barr Virus Infections

Interventions

Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Ming-yuan Chen, MD, PhD

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Ming-yuan Chen, MD, PhD

CONTACT

86-13903052650; chmingy@mail.sysu.edu.cn

Jiong-lin Liang, MD

CONTACT

86-13172018626; liangjl@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professior, Chief physician

Model Details: All participants will be tested for Epstein-Barr virus (EBV) associated biomarkers, including the two-antibody method (VCA-IgA and EBNA1-IgA), BNLF2b total antibodies (P85-Ab), and plasma EBV DNA. Furthermore, novel screening biomarkers, such as next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, will be explored.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: January 24, 2025
• Primary Completion: January 23, 2026
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 11, 2025

Record last verified: 2025-01

Locations

CN (1)