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.

承包商应向美国国立卫生研究院国家癌症研究所癌症预防司生物统计研究小组提供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。计算机相关支持分为三大类：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（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可以减少这些癌症的死亡率。该试验的基本原理是癌症筛查可能有助于更早发现和治疗疾病。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。 出于描述目的，这四种癌症的筛查研究可以被视为四个独立的项目。 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。参与 PLCO 研究的 75,000 名男性和 75,000 名女性均具有患肺癌的正常风险。此外，参加国家肺部筛查试验 (NLST) 的 21,000 名男性和 14,000 名女性是罹患肺癌的高风险人群。 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），初次就诊时，每年一次，持续 5 年 直肠指检（仅限男性），初次就诊时，每年一次，持续 3 年 首次就诊时和研究 5 年后进行柔性乙状结肠镜检查 胸部 X 光检查：吸烟者在入境时进行检查，并每年进行一次检查，持续 3 年。 （肺癌筛查） 从不吸烟的人在进入时和每年都进行了测试，持续两年。 （肺癌筛查） CA-125 血液检测（仅限女性），初次就诊时进行，并且每年进行一次，持续 5 年 经阴道超声检查（仅限女性），初次就诊时进行，每年一次，持续 3 年 对照组接受常规护理。 在 NLST 中，参与者被随机分配接受螺旋计算机断层扫描（螺旋 CT）筛查或普通 X 射线筛查。参与者在基线时进行筛查，此后两年每年进行一次筛查。 请注意，这些是随机对照试验，其终点旨在测试筛查的引入是否会降低相关特定癌症的死亡率。