Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 11,625
- 试验地点
- 1
- 主要终点
- positive predictive value
研究概览
简要总结
The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.
详细描述
The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 62 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •residents in Southern China
- •30-62 years old
- •a first-degree relative of at least one nasopharyngeal carcinoma patient
- •no medical record of nasopharyngeal carcinoma
- •Eastern Cooperative Oncology Group score of 0-2
- •be able to comprehend, sign, and date the written informed consent document to participate in the study
排除标准
- •history of nasopharyngeal carcinoma
- •heavy cardiovascular, liver or kidney disease
- •on systemic steroid or immunosuppressant treatment or active autoimmune disease
结局指标
主要结局
positive predictive value
时间窗: 3 years
the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results
negative predictive value
时间窗: 3 years
the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results
次要结局
- specificity(3 years)
- early diagnose rate(3 years)
- sensitivity(3 years)
- cost-effectiveness(3 years)
研究者
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University