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）本试点研究的目标 以统计上精确的方式描述长的行为 患有以下疾病的受试者的足月纵向前列腺特异性抗原 (PSA) 水平 良性前列腺患者的前列腺癌 (CP) 增生（BPH），以及没有任何诊断的受试者。 两次 计划统计建模的框架先于 诊断和治疗前。 科目是从 VA 中选择的 规范老龄化研究 (VANAS)，一项针对 2,200 人的长期波士顿地区队列研究 男性退伍军人每三年进行一次体检并储存冷冻血清样本 以供将来分析。 超过 80 名参与者被诊断患有脑瘫。 一个 从其中随机选择了相似数量的参与者 被诊断患有 BPH 的受试者，并随机选择相同数量的受试者 没有任何诊断的受试者。 这三组构成了本研究 人口对这项提案的支持。 为此需要三个组件 项目：(i) 完成所有人群纵向 PSA 水平的测量 研究组的参与者，（ii）获得临床相关的 通过图表审查所有研究参与者的信息，以及（iii）仔细 基于PSA分层纵向统计模型的分析 每个组和每个时间范围随时间变化的水平。 重要的 诸如年龄之类的协变量将被纳入所有此类模型中。 长的 本研究的术语目标，超出了本研究的范围 项目，有多个。 其中包括确定一个优化的早期 基于纵向 PSA 水平的 CP 检测策略 基线 PSA 水平与 PSA 增长率的结合 测量，在策略中纳入纵向“免费 PSA”水平， 开发软件以促进此类临床实施 纵向 PSA 水平的策略、测量和分析 整个 VANAS 队列以进行精细的统计表征，以及 测量前列腺疾病的疾病特定生活质量指数 以及随后与纵向 PSA 行为的相关性。