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：（申请人描述）本试验研究的目的 是以统计学上精确的方式来描述长期 受试者中的长期纵向前列腺特异性抗原（PSA）水平 前列腺癌（CP），良性前列腺受试者 前列腺增生（BPH）和无任何诊断的受试者。 两个时间 计划进行统计建模的帧优先于 诊断和治疗前。 受试者选自退伍军人事务部 规范老化研究（VANAS），一项长期的波士顿地区队列研究，2200人 男性退伍军人，每三年进行一次体检， 以便将来分析。 超过80名参与者被诊断患有CP。 一 类似数量的参与者是从 被诊断为BPH的受试者，以及随机从 没有任何诊断的人。 这三个小组组成了这项研究 人口对于这项提案。 为此需要三个组成部分 项目：（一）完成所有国家的纵向PSA水平测量 研究组的参与者，（ii）获得临床相关的 通过对所有研究参与者的图表审查提供信息，以及（iii）仔细 基于PSA分层纵向统计模型的分析 每个群体和每个时间段的水平。 重要 诸如年龄等协变量将被纳入所有这些模型。 长 本研究的长期目标，这是本范围之外的 项目，是多方面的。 其中包括确定优化的早期 基于纵向PSA水平的CP检测策略， 基线PSA水平和PSA升高率 测量，在策略中纳入纵向“游离PSA”水平， 开发软件，促进临床实施， 策略，测量和分析的纵向PSA水平， 整个VANAS队列的精确统计特征，以及 前列腺疾病的疾病特异性生活质量指数的测量 以及随后与纵向PSA行为的相关性。