DIAGNOSTIC CENTER

描述：此竞争对手续订应用程序(诊断中心)是 响应RFA DK94-18的UO1赠款。调查人员描述说 与良性疾病相关的广泛的经济和医疗问题 前列腺增生症。这项研究的总体目标是测试 药物干预在良性前列腺治疗中的作用 增生(BPH)，希望药物干预可以 事实证明，对一些患者来说，这比手术要好。的目标是 科罗拉多大学正在考虑的项目是 为全面试验建立所需的诊断中心。这个 诊断中心将对有材料的外周血进行分析 从几个临床中心送来；这些检测将包括前列腺癌 特异性抗原、黄体生成素、睾酮和 双氢睾丸素。血液化验将首先进行。 并在试验期间每年(见 协议)。 诊断中心将收到四个固定的和两个冷冻的18号口径 每个患者的针吸活组织检查都进入了研究。一系列 从石蜡包埋的固定针活检和从 冰冻的针吸活组织检查将被检查。这些幻灯片将被检查 由首席调查员和一名身份不明的 他将在支助的第二年被任命。成套的 此外，病理科亦可于下列地点索取幻灯片： 获取活组织检查的医院。《病理学》 在丹佛诊断中心进行的分析将记录在 与一起发送的材料中显示的标准格式 申请。石蜡包埋针吸活检的附加切片和 冷冻针吸活检的剩余材料将储存起来，用于 未来的研究。一开始就要做活组织检查 一年后，在研究结束时。 此外，还将进行免疫组织化学研究。 检测前列腺特异性抗原和MIB-1的表达 核扩散抗原。细胞凋亡将用 TUNEL免疫组织化学技术。形态测量评估将是 使用像这样的半自动图像分析方法 Shapiro等人(44)所描述的。 都列出来了。调查人员表示， 在他们的中心进行的试点研究，制造于 “不可能……无法获得有关预期范围的任何信息。 每个变量相对于以下任何度量的变化 治疗结果……然而，从已发表的文献来看， 预计280名患者的数据将足以产生 有意义的结果。“他们说，”……大约280个子集 我们会对个案进行详细分析。“

DESCRIPTION: This competing renewal application (Diagnostic Center) is for a UO1 grant in response to RFA DK94-18. The investigators describe the widespread economic and medical problems associated with benign prostatic hyperplasia. The overall goal of the study is to test the effectiveness of pharmacological intervention in benign prostatic hyperplasia (BPH) with the hope that pharmacological intervention may prove to be superior to surgery for some patients. The goal of the project under consideration from the University of Colorado is to establish the requested Diagnostic Center for the full-scale trial. The Diagnostic Center will perform assays on peripheral blood with materials sent from several clinical centers; these assays will include prostate specific antigen, luteinizing hormone, testosterone, and dihydrotestosterone. Blood chemistries will be carried out initially and annually for the duration of the trial (described in Appendix F of the protocol). The Diagnostic Center will receive four fixed and two frozen, 18-gauge needle biopsies from each patient entered into the study. A series of slides made from the paraffin-embedded fixed needle biopsies and from the frozen needle biopsies will be examined. These slides will be examined for diagnostic purposes by the principal investigator and an unidentified fellow who will be appointed in the second year of support. Sets of slides will also be made available to the departments of pathology from the hospitals from which the biopsies are obtained. The pathology analyzed in the Diagnostic Center in Denver will be recorded on a standard form that is displayed in the material sent with the application. Additional sections of paraffin-embedded needle biopsies and the remaining materials from frozen needle biopsies will be stored for research in the future. Biopsies will be carried out at the beginning of the study, after one year, and at the end of the study. In addition to the above, immunohistochemical studies will be carried out to assess the expression of prostate specific antigen and the MIB-1 nuclear proliferation antigen. Apoptosis will be evaluated with the TUNEL immunohistochemical technique. Morphometric evaluations will be carried out "using a semiautomated image analysis approach such as that described by Shapiro et al (44)." The step by step methods of staining are listed. The investigators state that conditions stipulated in the pilot study that was carried out in their center made in "impossible...to have any information about the expected ranges of variation for each of the variables with respect to any measures of treatment outcome...From the published literature, however, it is expected that data on 280 patients will be sufficient to produce meaningful results." They state that a "...subset of approximately 280 cases will have detailed analyses performed."