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: 8508161
• 负责人: PAUL J MARTIN
• 金额: $ 22.49万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2015-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8508161
• 关键词: Allogenic; Biological; Biometry; Blood; Blood specimen; Bone Marrow Transplantation; Cells; Clinical; Development; Disease; Donor Lymphocyte Infusion; Enrollment; Evaluation; Freezing; Future; HLA-DR Antigens; 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; hematopoietic cell transplantation; 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：患者入组、标本和数据管理以及生物统计学。该核心支持 项目1和2的四种方式。首先，核心负责招募患者并收集临床 项目1和项目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。获得该信息 主要是通过从西雅图癌症护理联盟的提供者和 转诊医生第二，核心小组负责从选定的病人身上取得血液样本 他们的结果对于造血细胞移植后的耐受性发展是有用的。 移植（HCT）。例如，当患者离开西雅图时，常规地从患者获取样本 HCT后约3个月以及HCT后1年返回进行评价时。另外还有按 在免疫抑制治疗开始前， 慢性GVHD患者。血液样本也从病人收集前后 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引起的GVHD之前， 发生在供体淋巴细胞输注后。这些样本可能特别有用，因为捐赠者 淋巴细胞输注仅用于免疫抑制药物治疗后无GVHD的患者 已经撤回了在这些患者中，可以监测免疫反应，而没有潜在的干扰 免受免疫抑制药物的影响。第三，核心负责处理血液 样本，计数表达CDS、CD 4、CDS、CD 25、CD 127和HLA-DR的细胞，并冷冻 供将来在项目1和2中使用的样本。第四，核心为数据管理提供支持， 对项目1和项目2的结果进行生物统计学分析。 相关性（参见说明）： 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 有害的免疫反应还不太清楚。该核心通过提供 项目1和项目2的研究者提供研究所需的临床信息和血液标本 这些研究将有助于确定控制这些有害免疫反应的机制。