Garg Kavita, Keith Robert L, Byers Tim, Kelly Karen, Kerzner Anne L, Lynch David A, Miller York E
Department of Radiology, University of Colorado, Denver Veterans Affairs Medical Center, USA.
Radiology. 2002 Nov;225(2):506-10. doi: 10.1148/radiol.2252011851.
To assess the feasibility of conducting a randomized controlled trial for lung cancer screening.
Subjects are being recruited into a randomized controlled trial to undergo either low-dose spiral computed tomography (CT) or observation. Subjects are from a high-risk group with known chronic obstructive pulmonary disease and sputum atypia and a moderate-risk group randomly selected from the general population of a Veterans Affairs Medical Center. All subjects must be 50-80 years of age with 30 or more pack-years of cigarette smoking and must not have undergone chest CT during the previous 3 years. Baseline screening CT is performed with 50 mA, 120 kVp, 5-mm collimation, and a pitch of 2. CT scan interpretation and management of nodules is based on Society of Thoracic Radiology guidelines. The chi(2) test for categoric data was used for statistical analysis.
To date, 304 eligible subjects have been contacted, and 239 (79%) have agreed to participate in the trial. One hundred nineteen (88%) of the 136 subjects in the high-risk group and 120 (71%) of the 168 subjects in the moderate-risk group agreed to randomization (P <.001). To date, 190 subjects have been randomized. Of the first 92 subjects examined with CT, 22 (40%) of 55 in the high-risk group and eight (22%) of 37 in the moderate-risk group had one to six noncalcified nodules that required follow-up (P =.07). In all but three subjects, nodules were smaller than 5 mm. Two of the three larger nodules were malignancies.
Findings of this study indicate that a randomized controlled trial of CT to screen for lung cancer is feasible.
评估开展肺癌筛查随机对照试验的可行性。
正在招募受试者进入一项随机对照试验，受试者将接受低剂量螺旋计算机断层扫描（CT）或观察。受试者来自已知患有慢性阻塞性肺疾病和痰异型性的高危组以及从退伍军人事务医疗中心普通人群中随机选取的中度风险组。所有受试者年龄必须在50至80岁之间，有30包年或以上的吸烟史，且在过去3年内未接受过胸部CT检查。基线筛查CT扫描采用50毫安、120千伏峰值、5毫米准直和2的螺距。CT扫描结节的解读和处理基于胸放射学会指南。分类数据采用卡方检验进行统计分析。
迄今为止，已联系304名符合条件的受试者，其中239名（79%）同意参与试验。高危组136名受试者中有119名（88%）、中度风险组168名受试者中有120名（71%）同意随机分组（P<.001）。迄今为止，已有190名受试者被随机分组。在最初接受CT检查的92名受试者中，高危组55名中有22名（40%）、中度风险组37名中有8名（22%）有1至6个需要随访的非钙化结节（P =.07）。除3名受试者外，所有结节均小于5毫米。3个较大结节中有2个为恶性肿瘤。
本研究结果表明，CT筛查肺癌的随机对照试验是可行的。
