MEASURING AND STATISTICAL MODELING OF SERIAL PSA LEVELS

描述：(申请人的描述)这项试点研究的目标 是以一种统计上精确的方式描述Long的行为 前列腺癌患者血清前列腺特异性抗原(PSA)水平的研究 良性前列腺癌患者的前列腺癌(CP) 前列腺增生症(BPH)，以及没有这两种诊断的受试者。两次 计划在其上进行统计建模的帧在 诊断，并在治疗之前。受试者选自退伍军人管理局 标准老龄化研究(VANAS)，波士顿地区2200人的长期队列研究 每三年进行一次体检并储存冰冻血清样本的男性退伍军人 以备将来分析之用。已有80多名参与者被诊断出患有脑瘫。一个 类似数量的参与者是从以下人员中随机挑选出来的 被诊断为良性前列腺增生症的受试者，以及从 两种诊断都没有的受试者。这三组人组成了这项研究 这项建议的人口。这需要三个组件 项目：(1)完成对所有人的纵向PSA水平的测量 研究小组的参与者，(Ii)获得临床相关 通过图表审查所有研究参与者的信息，以及(Iii)仔细 基于分层纵向统计模型的PSA分析 每组和每个时间范围内随时间变化的级别。重要 协变量，如年龄，将被纳入所有这些模型。《长河》 本研究的术语目标，不在本研究的范围内 项目，是多重的。这些措施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增长率 衡量标准，将纵向“游离PSA”水平纳入战略， 开发便于在临床上实施这种方法的软件 儿童纵向PSA水平的策略、测量和分析 用于改进统计特性的整个VANA队列，以及 前列腺病患者疾病特异性生活质量指数的测定 以及随后与纵向PSA行为的相关性。

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.