Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 369
- 试验地点
- 4
- 主要终点
- Estimate the time period for recruitment of 500 participants in LDCT screening study.
研究概览
简要总结
This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.
详细描述
Low dose computer tomography (LDCT) showed promising results in recently published studied. Lung cancer screening programs with fluorography introduced in USSR in 70s-80s showed shift to earlier stages with no data on mortality. No other studies or programs on lung cancer screening were introduced in Russia since then.
The purpose of this study is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using LDCT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. This cohort prospective study is planned to enroll at least 500 current or former smokers.
Patients will be screened by LDCT scan at baseline with recommendation to perform follow-up in case of any positive result. For nodes more than 10 mm full clinical examination is recommended. For nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. For nodes smaller than 3 mm and negative results annual LDCT is recommended. Patient with positive results will be followed until final clinical diagnosis.
Secondary outcomes include:
- Lung cancer diagnoses
- Lung cancer and overall mortality
- Quality of life assessment
- Complications of diagnostic and surgical procedures following a positive result.
- Comparison of independent radiological evaluation of scans.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50-75 years
- •30 or more pack-years of cigarette smoking history
- •Former smokers: quit smoking within the previous 10 years
- •Ability to tolerate CT procedure
- •Signed informed consent
排除标准
- •Any cancer other than nonmelanoma skin cancer or carcinoma in situ in the 5 years prior to eligibility assessment
- •Severe uncontrolled heart, vascular, respiratory or endocrine pathology.
- •Life-expectancy less than 1 year
- •History of lung cancer
- •History of lung surgery.
- •Acute respiratory disease
- •Hemoptysis.
- •Weight loss more than 10 kg in the 12 months prior to eligibility assessment
- •Participation in other cancer clinical trial
- •Chest CT examination in the 12 months prior to eligibility assessment.
研究组 & 干预措施
Low dose computed tomography
Patients will have one baseline LDCT scan.
干预措施: Low dose computed tomography (Procedure)
结局指标
主要结局
Estimate the time period for recruitment of 500 participants in LDCT screening study.
时间窗: 3 months
Primary outcome measure is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. The main concern comes from the possibility to recruit participant for screening as small amount of information is available about lung cancer screening options for high-risk population and general practitioners in different regions of the country.
次要结局
- All-cause mortality(5 years)
- Recruitment strategies(3 months)
- Lung cancer detection rate(One year)
- Lung cancer mortality(5 years)
- Nodule detection rate(3 months)