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、标本和数据管理以及生物统计学。这个核心支撑着 项目1和2以四种方式进行。首先，核心负责招募患者和收集临床数据 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)活动和免疫抑制治疗。该信息将被获取 主要是通过从西雅图癌症护理联盟和 推荐医生。其次，该中心负责从选定的患者那里获取血液样本 他们的结果对造血细胞后耐受性的发展是有信息的 移植(HCT)。例如，当患者离开西雅图时，通常会从他们身上获取样本。 在HCT后大约3个月，以及当他们在HCT后1年回来进行评估时。此外，a 在免疫抑制治疗开始前，我们共同努力收集血液样本。 患有慢性移植物抗宿主病的患者。患者的血液样本也在治疗前和治疗后采集。 供者淋巴细胞输注治疗HCT后复发的恶性肿瘤。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移植物抗宿主病之前，也会获得样本。 发生在供者淋巴细胞输注后。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移植物抗宿主病的患者 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 来自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、CD4、CDS、CD25、CD127和HLA-DR的细胞，以及冷冻 在项目1和2中供将来使用的样本。第四，核心为数据管理和 对项目1和2的结果进行生物统计分析。 相关性(请参阅说明)： 供者细胞对受者的免疫反应可导致并发症，当血液或骨髓 移植被用来治疗白血病和其他疾病。控制这些的生物机制 有害的免疫反应还没有被很好地理解。这一核心通过提供 项目1和项目2中的研究人员，具有研究所需的临床信息和血液样本 有助于确定控制这些有害免疫反应的机制的研究。