Prediction Model for Multiple Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Performance of PKUM model
研究概览
简要总结
This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.
详细描述
It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans
- •Patients with at least two nodules resected for pathological evaluation
排除标准
- •History of malignancy within 5 years
- •Presence of pneumonia or pleural effusion on thoracic CT scans
- •Patients with none or only one nodule resected
- •Patients with initial chemo-radiation therapy
结局指标
主要结局
Performance of PKUM model
时间窗: 3 months
Area under receiver operating characteristic curve (AUC) of PKUM model in predicting the probability of a nodule to be malignant in patients with multiple pulmonary nodules.
次要结局
- Comparison between PKUM model and clinicians(3 months)
- Performance of PKUM model in equivocal nodules which is difficult to judge by clinicians(3 months)
研究者
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital