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

Ming-Yuan Chen

Status

Enrolling

Conditions

Screening

Nasopharyngeal Carcinoma (NPC)

Epstein Barr Virus

Treatments

Diagnostic Test: Novel screening biomarkers

Diagnostic Test: EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA

Biological: Blood, nasopharyngeal swab and saliva

Diagnostic Test: Endoscopic examinations with or without biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT06870435

ZDWY.BYAFZZX.032

Details and patient eligibility

About

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.

Enrollment

68,649 estimated patients

Sex

All

Ages

30 to 69 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.