Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements at Multiple Centers in NPC Epidemic Regions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Plasma EBV DNA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-70 years
- •Histologically confirmed NPC or Non-NPC with positive plasma cell-free EBV DNA
排除标准
- •unsatisfactory performance status: Karnofsky scale (KPS) <= 70
- •Any severe intercurrent disease
- •Any contraindication of blood sampling
结局指标
主要结局
Plasma EBV DNA
时间窗: 1 Day
copy number of EBV DNA in plasma
次要结局
未报告次要终点
研究者
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University