Computer Support for Lung Cancer Screening in the PLCO Cancer Screening Trial

承包商应提供与计算机相关的技术支持服务，主要是系统设计、计算机编程、系统文档和操作支持，为国家癌症研究所、国家卫生研究院癌症预防部门的生物统计学研究小组提供支持。与计算机有关的支助主要分为三类：数据管理、系统设计和开发以及统计分析和建模。 承包商将为其提供支持的项目之一是前列腺癌、肺癌、结直肠癌和卵巢癌筛查试验，简称PLCO，这是一项大规模的临床试验，旨在确定某些癌症筛查测试是否可以降低这些癌症的死亡率。这项试验的基本原理是，癌症筛查可能使人们能够更早地发现和治疗这种疾病。癌症预防方面与测试引入筛查是否降低死亡率的设计有关。 为了描述的目的，这四种癌症的筛查研究可以被认为是四个独立的项目。 肺癌筛查研究的目的是评估肺癌筛查测试减少PLCO研究中四种癌症之一死亡的能力。有75,000名男性和75,000名女性参与了PLCO的研究，他们患肺癌的风险正常。此外，有21,000名男性和14,000名女性参加了国家肺部筛查试验(NLST)，他们患肺癌的风险很高。 在PLCO试验中，参与者被随机分配到两组中的一组，干预组或对照组。干预组接受： PSA(仅限男性)，首次就诊时，每年5年 手指直肠检查(仅限男性)，首次就诊时，每年检查3年 初次就诊和研究5年后的柔性乙状结肠镜检查 胸部X线片：吸烟者在入院时和3年内每年进行检查。(肺癌筛查) 从未吸烟者在入境时和两年内每年进行测试。(肺癌筛查) CA-125血液检测(仅限女性)，首次就诊时，每年5年 经阴道超声(仅限女性)，首次就诊时，每年3年 对照组接受常规护理。 在NLST中，参与者被随机分配到使用螺旋CT(螺旋CT)或普通X光进行筛查。参与者在基线上进行筛查，在那之后的两年里每年进行筛查。 请注意，这些是随机对照试验，终点的设计是为了测试筛查的引入是否降低了特定癌症的死亡率。

The Contractor shall provide computer-related technical support services, primarily systems design, computer programming, system documentation and operational support to the Biometry Research Group, Division of Cancer Prevention, in the National Cancer Institute, the National Institutes of Health. The computer-related support falls into three main categories: data management, systems design and development and statistical analysis and modeling. One of the projects for which the Contractor will provide support is the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, or PLCO, which is a large-scale clinical trial to determine whether certain cancer screening tests reduces deaths from these cancers. The underlying rationale for the trial is that screening for cancer may enable discovery and treatment of the disease earlier. The cancer prevention aspect is related to the design that tests whether the introduction of screening reduces mortality. The screening studies for these four cancers can be considered as four separate projects for description purposes. The screening studies for lung cancer have as the objective to evaluate the ability of lung cancer screening tests to reduce deaths from one of the four cancers in the PLCO study. There are 75,000 men and 75,000 women participating in the PLCO study who are at normal risk for developing lung cancer. Additionally, there are 21,000 men and 14,000 women participating in the National Lung Screening Trial (NLST) who are at high risk of developing lung cancer. In the PLCO trial, participants are randomly assigned to one of two groups, the intervention group or the control group. The intervention group receives: PSA (men only), at initial visit and annually for 5 years Digital rectal exam (men only), at initial visit and annually for 3 years Flexible sigmoidoscopy, at initial visit and after 5 years in study Chest X-ray: smokers had test at entry and annually for 3 years. (lung cancer screening) Never smokers had the test at entry and annually for 2 years. (lung cancer screening) CA-125 blood test (women only), at initial visit and annually for 5 years Transvaginal ultrasound (women only), at initial visit and annually for 3 years The control group receives usual care. In the NLST, participants are randomly assigned to either screening with spiral computed tomography (spiral CT) or usual xray. Participants are screened at baseline and yearly for two years after that. Note that these are randomized controlled trials where the endpoints are designed to test whether the introduction of screening reduces mortality from the particular cancer in question.