Crawford E L, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder S A, Boulos A M, Nana-Sinkam P, Massion P P, Arenberg D A, Midthun D, Mazzone P J, Nathan S D, Wainz R, Silvestri G, Tita J, Willey J C
Department of Pulmonary and Critical Care, The University of Toledo Medical Center, Toledo, OH, USA.
Department of Biostatistics, Henry Ford Hospital System, Detroit, MI, USA.
BMC Pulm Med. 2016 Jan 22;16:16. doi: 10.1186/s12890-016-0178-4.
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.
METHODS/DESIGN: 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.
肺癌风险检测（LCRT）试验是一项前瞻性队列研究，比较了LCRT检测结果为阳性或阴性的人群中的肺癌发病率，LCRT是一种在正常支气管上皮细胞（NBEC）中检测的15基因检测。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；以及生物样本库的建立。
方法/设计：符合条件的参与者年龄在50 - 90岁之间，为目前或既往吸烟者，有20包年或以上的吸烟史，无肺癌，且愿意接受支气管镜刷检以收集NBEC样本。从每个受试者收集NBEC、外周血样本、基线CT以及医学和人口统计学数据。
在两年时间（2010 - 2012年）内，12个地点共招募了403名受试者。基线时，384名受试者仍在研究中，平均年龄和吸烟史分别为62.9岁和50.4包年，34%为目前吸烟者。157名（54%）存在阻塞性肺疾病（FEV1/FVC <0.7）。支气管镜刷检未出现严重不良事件。建立了NBEC和匹配的外周血生物样本库。入组人群的人口统计学构成代表了LCRT目标人群。具体而言，根据基线人群特征，我们预计该队列中的肺癌发病率将代表符合低剂量计算机断层扫描（LDCT）肺癌筛查条件的人群。在该人群中，通过支气管镜刷检/支气管镜检查收集NBEC是安全且耐受性良好的。这些发现支持了在这项前瞻性研究中测试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范围，并推迟对肺癌风险结果表明较低的个体进行筛查的时间。对于这些个体，因一生仅进行一次用于LCRT的支气管镜样本采集所带来的小风险，可能会被其CT相关风险的降低所抵消。LCRT生物样本库将有助于对慢性阻塞性肺疾病（COPD）和/或肺癌风险的遗传基础进行更多研究。
LCRT研究，NCT 01130285，于2010年5月24日在Clinicaltrials.gov注册。
