Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Autoantibody panel with best clinical performance in Chinese population
研究概览
简要总结
Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 or above.
- •Individuals complying with either of the following
- •diagnosed as lung cancer (histopathologically confirmed);
- •diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
- •without pulmonary nodule but with lung cancer risk factor, age & gender matched recruited lung cancer patients.
- •Participant is willing and able to provide necessary information required in CRF.
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •History of any cancer;
- •Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.
结局指标
主要结局
Autoantibody panel with best clinical performance in Chinese population
时间窗: Oct.30, 2020
The combination which can achieve best sensitivity at 90% specificity, and its sensitivity, accuracy and PPV.
次要结局
未报告次要终点
研究者
Bai Chunxue
Chairman
Chinese Alliance Against Lung Cancer