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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening cohort | Experimental | Participants aged between 30 and 69 years old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood, nasopharyngeal swab and saliva | Biological | Collect blood, nasopharyngeal swab and saliva samples from participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative predictive value (NPV) | NPV refers to the proportion of positive negative results that are true negatives. | At screening, 3 years and 10 years thereafter. |
| Early diagnosis rate of nasopharyngeal carcinoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-yuan Chen, MD, PhD | Contact | 86-13903052650 | chmingy@mail.sysu.edu.cn | |
| Jiong-lin Liang, MD | Contact | 86-13172018626 | liangjl@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-yuan Chen, MD, PhD | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
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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.
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| EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA | Diagnostic Test | Detect EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA for all participants. |
|
| Novel screening biomarkers | Diagnostic Test | Next-generation sequencing for EBV and castoff cells using nasopharyngeal swabs, etc.. |
|
| Endoscopic examinations with or without biopsy | Diagnostic Test | High-risk participants will refer to endoscopic examinations with or without biopsy |
|
The proportion of nasopharyngeal carcinoma patients diagnosed at stages I and II according to the 9th version of AJCC TNM system.
| At screening, 3 years and 10 years thereafter. |
| Number needed to screen (NNS) | NNS refers to the amount of screening participants to identify one nasopharyngeal carcinoma case. | At screening, 3 years and 10 years thereafter. |
| Nasopharyngeal Carcinoma Death Rates | Nasopharyngeal Carcinoma deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study. | At screening, 3 years and 10 years thereafter. |
| Death Rates From All Causes | Deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study. | At screening, 3 years and 10 years thereafter. |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D003949 | Diagnostic Techniques, Surgical |
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