Bronchoscopy Screening of High-risk Population of Lung Cancer With Severe Smoking
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The effect of AFB and WLB screening （the positive rate of lung cancer）on LDCT screening negative at high risk for lung cancer was analyzed.
研究概览
简要总结
Based on the previous work of LDCT screening, in order to improve the screening rate of central lung cancer for LDCT negative and severe smokers, the investigators plan to conduct China's first large-scale fluorescent bronchoscopy screening test.
详细描述
CT scan is a commonly used method for clinical screening for early lung cancer, but research shows that LDCT scan has a higher detection rate for peripheral lesions (often adenocarcinoma), and a lower detection rate for central lung cancer (mostly squamous cell carcinoma). Fluorescent bronchoscopy uses the principle of differentiating fluorescence in different tissues to distinguish normal parts from diseased parts. It is often used for screening of central early lung cancer.Based on the results of the investigator's previous research, the investigators plan to conduct a second round of community screening-bronchoscopy screening, and perform white light bronchoscopy and autofluorescence bronchoscopy screening for high-risk groups of lung cancer with heavy smoking (≥400 years) and no obvious lung nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-75 years;
- •have a smoking history of ≥20 pack years; if participants quit smoking, it should be <15 years;
- •Chest LDCT examination within one and a half years without obvious abnormalities or calcified nodules or non-calcified nodules and no signs of malignancy
排除标准
- •Non-smokers or mild smokers;
- •There are contraindications to bronchoscopy, such as active hemoptysis, unstable angina pectoris, coagulation dysfunction, anesthesia allergy, etc .;
- •Refusing to sign informed consent;
- •The operator believes that the patient has other conditions that are not suitable for bronchoscopy.
结局指标
主要结局
The effect of AFB and WLB screening （the positive rate of lung cancer）on LDCT screening negative at high risk for lung cancer was analyzed.
时间窗: one year
ALB and WLB were screened for LDCT screening for lung cancer negative severe smokers. The effect of AFB and WLB screening on LDCT screening negative lung cancer at high risk was analyzed.
次要结局
- The diagnostic efficacy of WLB and AFB in lung cancer was compared(one year)
- Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.(one year)
- RGB（red-green-blue） chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.(one year)
- The independent risk factors of lung cancer in high-risk groups were Identified.(one year)
研究者
Jiayuan Sun
Director, Department of Endoscopy, Shanghai Chest Hospital
Shanghai Chest Hospital