Methods of Computed Tomography Screening and Management of Lung Cancer in Tianjin: A Population-based Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- number of clinically diagnosed lung cancer
研究概览
简要总结
European lung cancer screening studies using computed tomography (CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time (VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.
详细描述
In this population-based study, participants will undergo a low-dose chest CT scan for two rounds. At baseline, the first CT scan will be performed in all participants and their data will be collected. One-year after the baseline, a second CT scan will be performed and data will be collected again. CT images of each participant will be read twice independently by two groups of readers after the baseline and 1-year follow-up scans. In the first reading, the detected lung nodules are evaluated for diameter and managed according to a routine diameter-based protocol. The clinical management of participants are based on the first reading. In the second reading, each scan will be interpreted again by radiologists, blinded to the first reading. Semi-automated volumetry software will be used. The lung nodules will be evaluated for volume and management will be simulated according to a European volume-based protocol. Participants will be followed up and any diagnosis of lung cancer and related information will be collected at the fourth year through the hospital information system and by contacting the participants or their relatives.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-74 years;
- •Resident in the Hexi district of Tianjin city for at least 3 years;
- •Having no self-reported history of any malignant tumor.
排除标准
- •Pregnant woman will be excluded.
研究组 & 干预措施
lung cancer screening
Participants will undergo a chest CT scan in the Department of Radiology at Tianjin Cancer Hospital. All scans will be performed using the same CT system: Definition AS. Two readings of the images will be performed. In the first image reading, the CT images will be read by specially trained Chinese resident radiologist and checked by one of two senior Chinese radiologists. Lung Cancer Screening (version 2. 2018) Guidelines of the National Comprehensive Cancer Network (NCCN) will be used for the management of lung nodules. This guideline recommends management of lung nodules based on diameter. In the second reading, a semi-automated volumetry software will be used to measure the volume and evaluate the other parameters of lung nodules.
At baseline and one year after baseline, data about general characteristics, risk factors of lung cancer, and health status of the participants will be collected.
干预措施: lung cancer screening (Other)
结局指标
主要结局
number of clinically diagnosed lung cancer
时间窗: at the fourth year from baseline
The number of clinically diagnosed lung cancer will be collected through the hospital information system and by contacting the participants or their relatives using a questionnaire.
number of lung cancer death
时间窗: at the fourth year from baseline
The number of lung cancer death will be collected through the hospital information system and by contacting the relatives of the participants using a questionnaire.
次要结局
未报告次要终点