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| Name | Class |
|---|---|
| Wuzhou Red Cross Hospital | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
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Plasma Epstein-Barr virus (EBV) DNA will be measured in native plasma samples of nasopharyngeal carcinoma (NPC) patients, respectively, by three medical centers and a qualified laboratory in Southern China, the highest endemic area of NPC. Passing-Bablok regression and difference plots will be used to compare results from each center to the all-method median and mean values. Agreement among methods will be evaluated against bias derived from a biological variation.
The investigators intend to collect EBV DNA positive plasma samples of NPC patients, distribute the samples to four test centers and compare the measurement results to obtain the current status of the agreement of plasma EBV DNA measuring at different centers with various measurement systems in the endemic regions of NPC. A series of statistical analyses including Cohen's Kappa, intraclass correlation coefficient, and Passing-Bablok regression will be adopted for the consistency test. A harmonization study by using the same calibrators will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nasopharyngeal carcinoma patients | Plasma EBV DNA quantification by quantitative polymerase chain reaction (qPCR) assays in different medical centers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma EBV DNA qPCR test | Diagnostic Test | Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma EBV DNA | copy number of EBV DNA in plasma | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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NPC patients or Plasma EBV DNA positive people
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD, PhD | Contact | 86-20-8734-3361 | chmingy@mail.sysu.edu.cn | |
| Si-Yuan Chen, MD | Contact | 86-18711150216 | chensy@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD, PhD | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Peripheral blood will be collected into ethylenediaminetetraacetic acid (EDTA)-coated tubes and centrifuged, the plasma will be recovered and frozen at -80℃ until the test.
| 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 |