MEASURING AND STATISTICAL MODELING OF SERIAL PSA LEVELS

系列 PSA 水平的测量和统计建模

• 批准号: 2733338
• 负责人: Steven J Skates
• 金额: $ 3.32万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-18 至 1999-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2733338
• 关键词: aging; benign prostate hyperplasia; blood chemistry; carcinoma; clinical research; data collection; human data; human tissue; longitudinal human study; male; mathematical model; medical records; model design /development; neoplasm /cancer diagnosis; pathologic process; prostate neoplasms; prostate specific antigen; statistics /biometry

DESCRIPTION: (Applicant's Description) The objectives of this pilot study are to characterize in a statistically precise manner the behavior of long term longitudinal prostate specific antigen (PSA) levels in subjects with carcinoma of the prostate (CP), in subjects with benign prostatic hyperplasia (BPH), and in subjects without either diagnosis. Two time frames over which the statistical modeling is planned are prior to diagnosis, and prior to treatment. The subjects are chosen from the VA Normative Aging Study (VANAS), a long term Boston area cohort study of 2,200 male veterans with triannual medical exams and frozen serum samples stored for future analyses. Over 80 participants have been diagnosed with CP. A similar number of participants have been randomly selected from among subjects diagnosed with BPH, and the same number randomly selected from subjects without either diagnosis. These three groups form the study population for this proposal. Three components are required for this project: (i) completing measurement of longitudinal PSA levels in all participants in the study group, (ii) obtaining clinically relevant information via chart reviews on all study participants, and (iii) a careful analysis based on hierarchical longitudinal statistical models for PSA levels over time for each group and for each time frame. Important covariates such as age will be incorporated in all such models. The long term objectives of this research, which are outside the scope of this project, are multiple. These include determining an optimized early detection strategy for CP based on longitudinal PSA levels which utilizes the baseline PSA level jointly with the rate of increase in PSA measurements, inclusion of longitudinal "free PSA" levels in the strategy, development of software which facilitates clinical implementation of such strategies, measurement and analysis of longitudinal PSA levels in the entire VANAS cohort for refined statistical characterization, and measurement of disease specific quality of life indices for prostate disease and subsequent correlation with longitudinal PSA behavior.

描述：（申请人的描述）该试点研究的目标 要以统计精确的方式表征长长的行为 术语纵向前列腺特异性抗原（PSA）水平 前列腺癌（CP），患有良性前列腺的受试者 增生（BPH）和没有任何诊断的受试者。 两次 统计建模计划之前 诊断和治疗前。 主题是从VA中选择的 规范性老化研究（VANAS），一项长期波士顿地区队列研究的2200 男性退伍军人进行三角医学检查和储存的冷冻血清样品 用于将来的分析。 超过80名参与者被诊断出患有CP。 一个 从中间随机选择了类似数量的参与者 被诊断为BPH的受试者，从 没有任何诊断的受试者。 这三组构成了研究 该提议的人口。 为此需要三个组件 项目：（i）完成所有纵向PSA水平的测量 研究组的参与者（ii）获得临床相关的参与者 通过有关所有研究参与者的图表审查的信息，以及（iii）仔细的 基于PSA的分层纵向统计模型的分析 每组和每个时间范围的时间级别。 重要的 诸如年龄之类的协变量将纳入所有此类模型中。 长 本研究的术语目标，超出了此范围 项目，是多个。 这些包括确定早期优化 基于纵向PSA水平的CP检测策略 基线PSA水平与PSA的增加率共同 测量，在策略中包括纵向“自由PSA”水平， 开发促进此类临床实施的软件 纵向PSA水平的策略，测量和分析 整个用于精制统计特征的瓦斯队队， 测量疾病特定的前列腺疾病生活质量指数 并随后与纵向PSA行为相关。