NCT00512746已完成不适用
A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,569
- 试验地点
- 10
- 主要终点
- Proportion of lung cancer that is diagnosed as stage I or II
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Surveillance
Other
Screened arm
干预措施: cytology and cytometry specimen collection procedure (Other)
Surveillance
Other
Screened arm
干预措施: Chest x ray (Other)
Surveillance
Other
Screened arm
干预措施: Autofluorescence bronchoscopy (Procedure)
Surveillance
Other
Screened arm
干预措施: CT scan (Procedure)
Control
Active Comparator
Control arm
干预措施: Chest x ray (Other)
结局指标
主要结局
Proportion of lung cancer that is diagnosed as stage I or II
时间窗: 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
次要结局
- Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)(5 Years)
- Proportion of patients in the surveillance arm who have abnormal sputum cytology(5 Years)
- Proportion of patients in the surveillance arm who have abnormal sputum cytometry(5 Years)
- Death from lung cancer(Up to 15 years)
- Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)(5 Years)
- Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry(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(5 Years)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
National Lung Screening Trial (NLST) ScreeningLung CancerNCT00047385National Cancer Institute (NCI)53,454
已完成
不适用
CT Scans in Screening for Lung Cancer in Current and Former SmokersLung CancerNCT00625690University of Nebraska100
Unknown
不适用
Screening Methods in Finding Lung Cancer Early in Current or Former SmokersTobacco Use DisorderLung CancerNCT00751660British Columbia Cancer Agency2,504
已完成
不适用
Digital Mammography Screening Trial (ACRIN6652)Breast CancerNCT00008346American College of Radiology Imaging Network49,528
已完成
2 期
Sputum Cytology in Screening Heavy Smokers For Lung CancerLung CancerNCT00103363University of Colorado, Denver3,270