Validation of Low-dose Spiral CT for Early Diagnosis of Lung Cancer in a High Risk Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,203
- 试验地点
- 1
- 主要终点
- To determine the prevalence of malignant pulmonary disease at the first CT examination
研究概览
简要总结
The purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.
详细描述
Lung carcinoma is one the most fatal cancer in the world. The enormous fatality rate reflects the limited chance of cure, with a dismal overall 5-year survival rate of approximately 14%. The prognosis of lung cancer depends largely on early detection and immediate treatment prior to metastatic spread. For Stage 1 lung cancer the 5-year survival rate can be as high as 70% . These data suggest that early detection and surgical treatment would have a huge beneficial effect on the lung cancer population. We developed a single arm observational study for the early detection of lung cancer with low dose CT scan in high risk asymptomatic subjects. A mainly non invasive algorithm for management of undetermined nodules was designed including low dose CT at three months for baseline nodules with diameter between 5 and 8 mm, a PET scan for nodules larger that 8 mm (not reduced after antibiotics and one month follow up CT). Lesions increasing in diameter or in density or positive nodules at CT/PET were sent to surgical biopsy (videothoracoscopic approach preferred).
Spirometry was done in all subjects prior to CT scan to evaluate correlation between BPCO and lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by multiplying the number of packs per day by the total number of years smoked)
- •Former smoker should have stopped smoking within the 10 years before the inclusion in the study protocol
排除标准
- •Not currently suffering from malignant disease or having had malignant disease within the last 5 years
- •Not having known pulmonary pathology
- •Not having performed a chest CT scan during the last 2 years
结局指标
主要结局
To determine the prevalence of malignant pulmonary disease at the first CT examination
时间窗: once after enrollment
CT scan
To assess the radiological detection of disease during the 10 year follow-up
时间窗: once per year for a 10 year follow-up period
CT scan
次要结局
- To determine the overall resectability of detected malignant tumours(once after detection of malignancy)