ISRCTN80745975已完成3 期
A randomised controlled trial of surveillance for the early detection of lung cancer in an at risk group
niversity College London (UK)0 个研究点目标入组 1,568 人开始时间: 2007年3月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,568
研究概览
简要总结
- 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26138736 2. 2012 qualitative results from interviews of a sample of people accepting and declining participation in: https://www.ncbi.nlm.nih.gov/pubmed/22106018 (added 15/04/2019) 3. 2012 results presented at the European Respiratory Society Annual Congress 2012 in: https://erj.ersjournals.com/content/40/Suppl_56/1638 (added 15/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Amended as of 03/10/2008:
- •Point two of the inclusion criteria has been amended as follows:
- •2. Ex-smokers who have quit within 8 years with a greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking
- •Initial information at time of registration:
- •1. Current smokers: greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking
- •2. Ex-smokers who have quit within 5 years with a greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking
- •3. No upper age limit but life expectancy must be at least 5 years
- •4. No history of malignant disease during the previous 5 years except non-melanomatous skin cancers
- •5. No other serious co-morbidity
- •6. Written informed consent
- •7. Mild to moderate COPD as defined by the Global Initiative on Obstructive Lung Disease (GOLD) criteria
- •8.1. Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 70
- •8.2. FEV1 greater than or equal to 80% predicted
- •9. Moderate:
- •9.1. FEV1/FVC less than 70%
- •9.2. FEV1 50-80% predicted
- •(Spirometric values will be taken post bronchodilator according to the recommendations in the GOLD criteria)
排除标准
- •1. Inadequate lung function (FEV1 less than 50% predicted after bronchodilator)
- •2. History of malignant disease during the previous 5 years except non melanomatous skin cancers
- •3. Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in the trial
- •4. Any disorder making reliable informed consent impossible
- •5. Patient unlikely to co-operate with a 5 year follow up
研究者
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