Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Relative risk of risk factors for mediastinal metastasis
研究概览
简要总结
The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- •Potentially operable
排除标准
- •M1 disease
- •Inoperable T4 disease
- •Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT
- •Confirmed supraclavicular lymph node metastasis
- •Pancoast tumours
- •T1 ground glass opacity nodule (with solid part 1<cm)
- •Solid T1 (1<cm)N0 M0 by CT & PET/CT
- •Inoperable patients (after evaluating medical and surgical operability)
- •Patients who refused surgical treatment
- •Contraindications for bronchoscopy
- •Drug reaction to lidocaine, midazolam, fentanyl
- •Pregnancy
结局指标
主要结局
Relative risk of risk factors for mediastinal metastasis
时间窗: When confirmative diagnosis are available in all subjects ;3 years
risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer.
次要结局
- Molecular test(for each subject; up to 60 days, available in all subjects ; 3 years)
- Diagnostic values of endoscopic staging(When confirmative diagnosis are available in all subjects ;3 years)
- Survival(After the diagnosis ; 7 years)
研究者
Bin Hwangbo
Principal Investigator
National Cancer Center, Korea