Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
2011年12月20日 更新者：University College, London
A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be easier to treat.
PURPOSE: This randomized clinical trial is studying screening tests or exams to see how well they work compared to usual care in finding early stage lung cancer in current or past smokers with chronic obstructive pulmonary disease.
研究概览
地位
完全的
详细说明
OBJECTIVES:
Primary
- To show that the proportion of lung cancer diagnosed at stage I or II is significantly greater in the surveillance arm than in the control arm.
Secondary
- Establish whether sputum cytology and/or cytometry can be employed to stratify patients with chronic obstructive pulmonary disease (COPD) according to their risk of developing incidence lung cancer.
- Identify patients with pre-invasive lesions in their airways and examine the risk of developing lung cancer in patients harboring these lesions.
- Provide an opportunity to archive blood samples from patients under surveillance to enable the identification of markers of disease progression.
- Examine the compliance of regular screening among patients in this high-risk group.
- Determine the proportion of patients in which it is not possible to provide a sputum screening result.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to recruiting site, age, gender, smoking history (current vs ex-smoker) and severity of chronic obstructive pulmonary disease (COPD) (mild vs moderate). Patients are randomized to 1 of 2 arms.
- Control arm: Patients are managed according to the usual practice of their hospital or general practice for their COPD treatment. They undergo no particular investigations except those that may arise due to a change in their clinical condition. Those patients who are not diagnosed with lung cancer during the course of the study are offered a chest x-ray after 5 years of follow-up.
- Surveillance arm: Patients undergo surveillance for 5 years. A sputum sample is collected for cytology and cytometry. If the sputum sample is normal the patient is asked to provide a sputum sample annually. If the sputum sample is abnormal the patient undergoes an annual spiral CT scan followed by autofluorescence bronchoscopy. At bronchoscopy, the following samples are taken: bronchial washings, bronchial brushings, and bronchial biopsies. Bronchoscopy is repeated every 4-12 months depending upon the histology results. If an invasive lesion is found, the patient is referred for treatment via the normal hospital systems. Any remaining sputum sample is stored frozen as part of the tissue bank associated with this trial.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
研究类型
介入性
注册 (实际的)
1569
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
England
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Cambridge、England、英国、CB23 3RE
- Papworth Hospital
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Coventry、England、英国、CV2 2DX
- Walsgrave Hospital
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Leeds、England、英国、LS1 3EX
- Leeds General Infirmary
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Leicester、England、英国、LE3 9QP
- University Hospitals of Leicester NHS Trust
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London、England、英国、SW3 6NP
- Royal Brompton Hospital
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London、England、英国、SW10 9NH
- Chelsea Westminster Hospital
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London、England、英国、WC1E 5DB
- University College Hospital - London
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Manchester、England、英国、M23 9LT
- Wythenshawe Hospital
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Sunderland、England、英国、SR4 7TP
- Sunderland Royal Hospital
-
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Northern Ireland
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Belfast、Northern Ireland、英国、BT9 7AB
- Respiratory Research Office Belfast City Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
DISEASE CHARACTERISTICS:
Inclusion criteria:
Meets 1 of the following criteria:
- Current smoker, defined as ≥ a 20 pack year smoking history and/or 20 year duration of smoking
- Ex-smoker who has quit smoking within the past 8 years AND has ≥ a 20 pack year smoking history and/or 20 year duration of smoking
Mild to moderate chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria
- Mild COPD: FEV_1/forced vital capacity (FVC) < 70%; FEV_1 ≥ 80% of predicted*
- Moderate COPD: FEV_1/FVC < 70%; FEV_1 50-80% of predicted* NOTE: *Spirometric values will be obtained post bronchodilator according to the recommendations in the GOLD criteria
Exclusion criteria:
- Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Life expectancy must be at least 5 years
Exclusion criteria:
- History of malignant disease within the past 5 years except non-melanomatous skin cancers
- Other serious co-morbidity
- Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in this trial
- Any disorder making reliable informed consent impossible
- Unlikely to co-operate with a 5 year follow-up
PRIOR CONCURRENT THERAPY:
- Patients may receive all concurrent therapy deemed to provide adequate care as decided by their medical doctors
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：控制
控制臂
|
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years.
This could help identify a lung cancer that may not have been associated with symptoms earlier.
|
|
其他：Surveillance
Screened arm
|
Samples tested and further interventions added if positive
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years.
This could help identify a lung cancer that may not have been associated with symptoms earlier.
The bronchial tree will be inspected first under white light and then under blue light.
All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
其他名称：
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of lung cancer that is diagnosed as stage I or II
大体时间：5 years
|
In the control arm, it is expected that only 15% of cancers will be detected early.
In the surveillance arm, we expect that at the time of the first screen, the detection rate of prevalence cancers will be about 3%, from data reported in CT screening studies
|
5 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
大体时间：5 Years
|
5 Years
|
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Proportion of patients in the surveillance arm who have abnormal sputum cytology
大体时间：5 Years
|
5 Years
|
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Proportion of patients in the surveillance arm who have abnormal sputum cytometry
大体时间：5 Years
|
5 Years
|
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Death from lung cancer
大体时间：Up to 15 years
|
Up to 15 years
|
|
Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)
大体时间：5 Years
|
5 Years
|
|
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
大体时间：5 Years
|
5 Years
|
|
Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung
大体时间：5 Years
|
5 Years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Stephen G. Spiro、University College London Hospitals
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年8月1日
初级完成 (实际的)
2011年3月1日
研究注册日期
首次提交
2007年8月6日
首先提交符合 QC 标准的
2007年8月6日
首次发布 (估计)
2007年8月8日
研究记录更新
最后更新发布 (估计)
2011年12月21日
上次提交的符合 QC 标准的更新
2011年12月20日
最后验证
2011年12月1日
更多信息
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