Computer Support for the Colon Cancer Screening in PLCO Cancer Screening Trials

PLCO 癌症筛查试验中结肠癌筛查的计算机支持

• 批准号: 8328460
• 负责人: WILLIAM LAKE
• 金额: $ 57.3万
• 依托单位: INFORMATION MANAGEMENT SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-10 至 2012-05-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8328460
• 关键词: Biometry; Blood Tests; CA-125 Antigen; Categories; Cessation of life; Clinical Trials; Colon Carcinoma; Colorectal Cancer; Computers; Contractor; Control Groups; Development; Disease; Division of Cancer Prevention; Documentation; Flexible fiberoptic sigmoidoscopy; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of prostate; Modeling; National Cancer Institute; Participant; Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; Randomized; Randomized Controlled Trials; Research; Risk; Screening for Ovarian Cancer; Screening for cancer; Screening procedure; Services; Smoker; System; Testing; Thoracic Radiography; Transvaginal Ultrasound; United States National Institutes of Health; Visit; Woman; cancer prevention; computer program; data management; design; digital; falls; group intervention; men; menthyl 3-(2-pyridylsulfinyl)acrylate; mortality; rectal; treatment as usual

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 colon cancer have as the objective to evaluate the ability of colon 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 colon cancer. 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 (colon cancer screening) Chest X-ray: smokers had test at entry and annually for 3 years. Never smokers had the test at entry and annually for 2 years. 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. 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.

承包商应提供计算机相关技术支持服务，主要是系统设计、计算机编程、系统文档和操作支持，以支持美国国立卫生研究院国家癌症研究所癌症预防部的生物统计学研究组。与计算机有关的支助福尔斯分为三大类：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、肺癌、结直肠癌和卵巢癌筛查试验（PLCO），这是一项大规模的临床试验，旨在确定某些癌症筛查试验是否能减少这些癌症的死亡人数。这项试验的基本原理是，筛查癌症可能有助于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。 这四种癌症的筛查研究可以被视为四个单独的项目进行描述。 结肠癌筛查研究的目的是评估结肠癌筛查试验减少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研究，他们有患结肠癌的正常风险。 参与者被随机分配到两个组中的一个，干预组或控制组。干预小组收到： PSA（仅男性），首次访视时和每年一次，持续5年 直肠指检（仅男性），首次访视时和每年一次，持续3年 首次访视时和研究5年后的软式乙状结肠镜检查（结肠癌筛查） 胸部X线检查：吸烟者在入组时进行检查，并每年进行一次，持续3年。 从不吸烟者在入境时进行测试，每年进行一次，持续2年。 CA-125血液检测（仅限女性），首次访视时和每年一次，持续5年 经阴道超声检查（仅限女性），初次访视时和每年一次，持续3年 对照组接受常规护理。 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降低了特定癌症的死亡率。