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

PLCO 癌症筛查试验中肺癌筛查的计算机支持

• 批准号: 7648739
• 金额: $ 84.93万
• 依托单位: INFORMATION MANAGEMENT SERVICES, INC.
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7648739
• 关键词: Computer; Support; Lung; Cancer; Screening

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.

承包商应为美国国家癌症研究所（National Cancer Institute），美国国家癌症研究所（National Cancer Institute），预防癌症预防司，主要是系统设计，计算机编程，系统文档和运营支持。与计算机相关的支持分为三个主要类别：数据管理，系统设计和开发以及统计分析和建模。 承包商将提供支持的项目之一是前列腺，肺，结直肠癌和卵巢癌筛查试验或PLCO，这是一项大规模临床试验，旨在确定某些癌症筛查测试是否会减少这些癌症的死亡。该试验的基本原理是筛查癌症可能会提前发现和治疗该疾病。预防癌症的方面与测试筛查引入是否降低死亡率的设计有关。 这四种癌症的筛查研究可以被视为四个独立的项目，以进行描述。 肺癌的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的死亡的能力。有75,000名男性和75,000名女性参加了PLCO研究，她们患肺癌的风险正常。此外，还有21,000名男性和14,000名妇女参加了患有肺癌高风险的国家肺筛查试验（NLST）。 在PLCO试验中，参与者被随机分配给两个组之一，即干预组或对照组。干预组收到： PSA（仅男子），初次访问和每年5年 初次访问和每年的数字直肠考试（仅男性）3年 柔性乙状结肠镜检查，初次访问和研究5年后 胸部X射线：吸烟者每年进行3年的入场测试。 （肺癌筛查） 从来没有吸烟者在入场时进行测试，并且每年都有2年的时间。 （肺癌筛查） CA-125血液检查（仅女性），初次访问和每年5年 经阴道超声（仅女性），初次访问和每年3年 对照组接受常规护理。 在NLST中，参与者被随机分配给使用螺旋计算机断层扫描（螺旋CT）或通常的X射线进行筛选。参与者在基线和每年进行两年后进行筛查。 请注意，这些是随机对照试验，其中设计端点是为了测试筛查的引入是否会降低所讨论的特定癌症的死亡率。