Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository.
Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository.
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DOI：
10.1186/s12890-016-0178-4
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发表时间：
2016-01-22
影响因子：
3.1
通讯作者：
Willey JC
中科院分区：
文献类型：
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作者：
Crawford EL;Levin A;Safi F;Lu M;Baugh A;Zhang X;Yeo J;Khuder SA;Boulos AM;Nana-Sinkam P;Massion PP;Arenberg DA;Midthun D;Mazzone PJ;Nathan SD;Wainz R;Silvestri G;Tita J;Willey JC
肺癌风险测试（LCRT）试验是一项前瞻性队列研究，比较LCRT阳性或阴性人群的肺癌发病率，LCRT是在正常支气管上皮细胞（NBEC）中测量的15个基因测试。本文的目的是描述研究设计、主要终点和安全性;入组个体的基线特征;以及生物标本库的建立。符合条件的参与者年龄为50-90岁，目前或以前吸烟者，吸烟史≥ 20包年，无肺癌，愿意接受支气管镜刷检活检以采集NBEC样本。收集每例受试者的NBEC、外周血样本、基线CT以及医学和人口统计学数据。在2年的时间跨度（2010-2012）内，12家研究中心入组了403例受试者。基线时，384例受试者仍在研究中，平均年龄和吸烟史分别为62.9岁和50.4包-年，34%的受试者目前吸烟。157例（54%）存在阻塞性肺疾病（FEV 1/FVC <0.7）。无严重不良事件与支气管镜刷拭相关。建立了NBEC和匹配的外周血生物标本库。入组的人口统计学组成可代表LCRT预期适用的人群。具体而言，基于基线人群特征，我们预计该队列中的肺癌发病率可代表适合进行低剂量计算机断层扫描（LDCT）肺癌筛查的人群。在该人群中，通过支气管刷检活检/支气管镜检查采集NBEC是安全的，耐受性良好。这些发现支持在本前瞻性研究中测试LCRT临床效用的可行性。如果得到验证，LCRT有可能显著缩小需要每年进行低剂量螺旋CT筛查以早期发现肺癌的人群，并延迟结果表明肺癌风险低的人群的筛查开始。对于这些个体，一生中进行一次支气管镜样本采集用于LCRT的小风险可能会被CT相关风险的降低所抵消。LCRT生物标本库将使更多的研究的遗传基础的COPD和/或肺癌的风险。LCRT研究NCT 01130285于2010年5月24日在Clinicaltrials.gov上注册。本文的在线版本（doi：10.1186/s12890-016-0178-4）包含补充材料，可供授权用户使用。
The Lung Cancer Risk Test (LCRT) trial is a prospective cohort study comparing lung cancer incidence among persons with a positive or negative value for the LCRT, a 15 gene test measured in normal bronchial epithelial cells (NBEC). The purpose of this article is to describe the study design, primary endpoint, and safety; baseline characteristics of enrolled individuals; and establishment of a bio-specimen repository. Eligible participants were aged 50–90 years, current or former smokers with 20 pack-years or more cigarette smoking history, free of lung cancer, and willing to undergo bronchoscopic brush biopsy for NBEC sample collection. NBEC, peripheral blood samples, baseline CT, and medical and demographic data were collected from each subject. Over a two-year span (2010–2012), 403 subjects were enrolled at 12 sites. At baseline 384 subjects remained in study and mean age and smoking history were 62.9 years and 50.4 pack-years respectively, with 34 % current smokers. Obstructive lung disease (FEV1/FVC <0.7) was present in 157 (54 %). No severe adverse events were associated with bronchoscopic brushing. An NBEC and matched peripheral blood bio-specimen repository was established. The demographic composition of the enrolled group is representative of the population for which the LCRT is intended. Specifically, based on baseline population characteristics we expect lung cancer incidence in this cohort to be representative of the population eligible for low-dose Computed Tomography (LDCT) lung cancer screening. Collection of NBEC by bronchial brush biopsy/bronchoscopy was safe and well-tolerated in this population. These findings support the feasibility of testing LCRT clinical utility in this prospective study. If validated, the LCRT has the potential to significantly narrow the population of individuals requiring annual low-dose helical CT screening for early detection of lung cancer and delay the onset of screening for individuals with results indicating low lung cancer risk. For these individuals, the small risk incurred by undergoing once in a lifetime bronchoscopic sample collection for LCRT may be offset by a reduction in their CT-related risks. The LCRT biospecimen repository will enable additional studies of genetic basis for COPD and/or lung cancer risk. The LCRT Study, NCT 01130285, was registered with Clinicaltrials.gov on May 24, 2010. The online version of this article (doi:10.1186/s12890-016-0178-4) contains supplementary material, which is available to authorized users.