Patient Enrollment, Specimen and Data Management, and Biostatistics

患者登记、样本和数据管理以及生物统计学

• 批准号: 8309107
• 负责人: PAUL J MARTIN
• 金额: $ 26.73万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8309107
• 关键词: Allogenic; Biological; Biometry; Blood; Blood specimen; Bone Marrow Transplantation; Cell Transplantation; Cells; Clinical; Development; Disease; Donor Lymphocyte Infusion; Enrollment; Evaluation; Freezing; Future; HLA-DR Antigens; Hematopoietic; IL2RA gene; IL7R gene; Immune; Immunobiology; Immunosuppression; Immunosuppressive Agents; Instruction; Left; Malignant Neoplasms; Medical Records; Monitor; Outcome; Patients; Pharmaceutical Preparations; Physicians; Process; Provider; Reaction; Recurrence; Research Personnel; Sampling; Specimen; abstracting; cancer care; chronic graft versus host disease; data management; graft vs host disease; leukemia; programs; research study

Core B: Patient enrollment, specimen and data management, and biostatistics. This core supports Projects 1 and 2 in four ways. First, the core is responsible for enrolling patients and collecting clinical information that is needed for Projects 1 and 2. Patients are categorized according to the presence of graft- versus-host disease (GVHD) activity and immunosuppressive treatment. This information is obtained primarily by abstracting medical records from providers at the Seattle Cancer Care Alliance and from referring physicians. Second, the core is responsible for procuring blood samples from selected patients who have outcomes that are informative for the development of tolerance after hematopoietic cell transplantation (HCT). For example, samples are routinely obtained from patients when they leave Seattle at approximately 3 months after HCT and when they return for evaluation at 1 year after HCT. In addition, a concerted effort is made to collect blood samples before the onset of immunosuppressive treatment in patients who develop chronic GVHD. Blood samples are also collected from patients before and after infusion of donor lymphocytes for treatment of recurrent malignancy following HCT. In these patients, blood samples are also obtained before immunosuppressive medications are given to treat any GVHD that might occur after donor lymphocyte infusion. These samples are likely to be particularly informative, since donor lymphocyte infusions are used only in patients who have no GVHD after immunosuppressive medications have been withdrawn. In these patients, immune reactions can be monitored with no potential interference from the effects of immunosuppressive medications. Third, the core is responsible for processing blood samples, enumerating cells that express CDS, CD4, CDS, CD25, CD127 and HLA-DR, and freezing samples for future use in Projects 1 and 2. Fourth, the core provides support for data management and biostatistical analysis of results from Projects 1 and 2. RELEVANCE (See instructions): Immune reactions of donor cells against the recipient can cause complications when blood or marrow transplantation is used to treat leukemia and other diseases. The biological mechanisms that control these harmful immune reactions are not well understood. This core strengthens the overall program by providing investigators in Projects 1 and 2 with the clinical information and blood specimens needed for research studies that will help to identify the mechanisms that control these harmful immune reactions.

核心 B：患者登记、样本和数据管理以及生物统计学。该核心支持 项目1和2有四种方式。首先，核心负责患者入组和临床收集 项目 1 和 2 所需的信息。根据移植物的存在对患者进行分类 抗宿主病（GVHD）活性和免疫抑制治疗。获得此信息 主要通过从西雅图癌症护理联盟的提供者和来自 转诊医生。其次，核心负责从选定的患者身上获取血液样本 其结果可为造血细胞后耐受性的发展提供信息 移植（HCT）。例如，通常在患者离开西雅图时采集样本 HCT 后约 3 个月以及 HCT 后 1 年返回评估时。此外，还有一个 在开始免疫抑制治疗之前，我们共同努力收集血液样本 患有慢性 GVHD 的患者。还采集了患者之前和之后的血液样本。 输注供体淋巴细胞用于治疗 HCT 后复发性恶性肿瘤。在这些患者中，血液 在给予免疫抑制药物治疗任何可能发生的 GVHD 之前也会采集样本。 发生在供体淋巴细胞输注后。这些样本可能会提供特别丰富的信息，因为捐赠者 淋巴细胞输注仅适用于免疫抑制药物后无 GVHD 的患者 已被撤回。在这些患者中，可以在没有潜在干扰的情况下监测免疫反应 免受免疫抑制药物的影响。三、核心负责处理血液 样本，计数表达 CDS、CD4、CDS、CD25、CD127 和 HLA-DR 的细胞，并冷冻 供项目 1 和 2 将来使用的示例。第四，核心提供数据管理和支持 对项目 1 和 2 结果的生物统计分析。 相关性（参见说明）： 当血液或骨髓发生变化时，供体细胞对受体的免疫反应可能会导致并发症 移植用于治疗白血病和其他疾病。控制这些的生物机制 有害的免疫反应尚不清楚。该核心通过提供 项目 1 和 2 的研究人员提供研究所需的临床信息和血液样本 研究将有助于确定控制这些有害免疫反应的机制。