Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40,000
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of different EBV associated biomarkers
研究概览
简要总结
All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually.
All subjects will also be followed by record linkage to Cancer Register and Population Register.
详细描述
Sample selection
- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.
Participants recruitment
- Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
- Face-to-face interviews are conducted by well-trained investigators.
Tests and follow up
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject residents in Zhongshan City or Wuzhou City
- •Subject has no medical record of nasopharyngeal carcinoma
- •Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- •Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
排除标准
- •Subject has heavy cardiovascular, liver or kidney disease.
- •Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
结局指标
主要结局
Sensitivity and specificity of different EBV associated biomarkers
时间窗: 5 years
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
Positive and negative predictive values of different EBV associated biomarkers
时间窗: 5 years
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC
次要结局
- Early diagnosis rate of nasopharyngeal carcinoma(5 years)
- Number needed to screen to identify one nasopharyngeal carcinoma(5 years)
研究者
Mingfang Ji
Dr. Mingfang Ji
Zhongshan People's Hospital, Guangdong, China