Screening and Diagnosing for Early Lung Cancer in Shanghai Communities With Imaging Procedures
试验速览
- 阶段
- 2 期
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer
研究概览
简要总结
Imaging procedures including chest X-ray and low-dose computed tomography may be effective in lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined with computer aided detection （CAD) is more effective than LDCT in screening of early lung cancer.
详细描述
The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided low-dose computed tomography and low-dose computed tomography in lung cancer screening for community individuals in Shanghai, China. Thus, an imaging protocol which can detect early lung cancer in asymptomatic high risk patients will be proposed.
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
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 55 to 74 years; smoking history of at least 30 pack-years; and if former smoker, have quit within 15 years
- •Age 50 or older ,20 or more pack-year history of smoking, and one additional risk factor (occupational exposure, residential radon exposure, cancer history, family history of lung cancer, history of lung disease)
- •Age 35 and one additional risk factor
- •Ability to accept LDCT examination and sign informed consent form
排除标准
- •Individuals with any symptoms suggestive of lung cancer （e.g., vigorous coughing, chest pain, weight loss, blood-stained sputum）
- •Individuals with acute pulmonary abnormalities or those in poor health conditions or those have metallic implants or devices in the chest or back will be excluded due to the potential impact on the results as well as difficulty of acquiring the images.
- •Pregnant women
研究组 & 干预措施
High-risk individuals
The elder and heavy smokers, which are high-risk individuals for early lung cancer. These subjects will be examined using "Observer nodule detection" and " Computer-aided nodule detection".
干预措施: Observer nodule detection (Behavioral)
High-risk individuals
The elder and heavy smokers, which are high-risk individuals for early lung cancer. These subjects will be examined using "Observer nodule detection" and " Computer-aided nodule detection".
干预措施: Computer-aided nodule detection (Device)
结局指标
主要结局
The sensitivities of low-dose computed tomography and low-dose computed tomography with computer aided detection in detecting early lung cancer
时间窗: 24months
A questionaire will be recorded for each subject, including demographics, smoking history and disease history, etc. If a pulmonary nodule was found, the location, shape, size, margin and density will be recorded. A subject with a suspected malignant nodule, which was detected either by a radiologist or computed-aiding detection software, will refer to a physician for further management. Finally, the sensitivities of radiologist or software detection will be calculated.
次要结局
- The false positive rates between low-dose computed tomography and low-dose computed tomography with computer aided detection will be compared(24months)
- Nodule detection rate(6 months)
研究者
Liu ShiYuan
Shanghai Changzheng Hospital
Shanghai Changzheng Hospital