Clinical Research

临床研究

• 批准号: 8395836
• 负责人: thomas matthew habermann
• 金额: $ 32.07万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-11 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8395836
• 关键词: Adverse event; Amendment; Area; Basic Science; Cells; Cessation of life; Clinic; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Unit; Clinical trial protocol document; Coagulation Process; Collaborations; Complement; Comprehensive Cancer Center; Consent; Core Facility; DNA; Data; Databases; Development; Enrollment; Ensure; Epidemiology; Farnesyl Transferase Inhibitor; Funding; Genes; Genetic Variation; Goals; Hemorrhage; Human; Immune response; Institution; K-Series Research Career Programs; Light; Link; Lymphoma; Malignant Neoplasms; Manuscripts; Mayo Clinic Cancer Center; Molecular Epidemiology; NF-kappa B; Newly Diagnosed; North Central Cancer Treatment Group; Patients; Peripheral; Population Sciences; Protocols documentation; Publications; Publishing; Qualifying; Quality Control; RNA; Reporting; Research; Research Personnel; Research Project Grants; Resource Sharing; Resources; Risk; SDZ RAD; Seminal; Serum; Specialized Program of Research Excellence; Therapeutic Clinical Trial; Tipifarnib; Translational Research; Tumor Tissue; Vitamin D Deficiency; Work; abstracting; career development; complement pathway; epidemiologic data; human subject; mTOR Inhibitor; novel; outcome forecast; peripheral blood; programs; research and development; research study

The UI/MC SPORE Clinical Research Core (CRC) has as its primary goal to be the direct translational link between research projects and clinical research emanating from these projects. The specific aims of the CRC are to: 1) coordinate and perform SPORE clinical trials protocols; 2) manage SPORE observational epidemiology protocols and partner with the Molecular Epidemiology Resource (MER). The CRC provides a critical link between clinical research and the specific projects, cores, and developmental research. The CRC is co-directed by Thomas M. Habermann, MD, at the Mayo Clinic Cancer Center and Brian Link, MD, at the Holden Comprehensive Cancer Center. A key function of the CRC is to coordinate the development of clinical trials, assist in patient accrual, manage protocol amendments, report adverse events te appropriate agencies, and provide comprehensive quality control on clinical trial data. For the MER, the CRC consents newly diagnosed lymphoma patients, abstracts and enters clinical and epidemiologic data, and systematically follows all MER patients through death. Tumor tissue and peripheral bleed serum, cells, DNA, and RNA that are prospectively collected, stored and tracked by the Biospecimens Core are linked to the CRC database. This provides SPORE investigators integrated and centralized access for lymphoma research projects. During the last funding cycle, 10 therapeutic clinical trials were initiated or active, including 2 InterSPORE trials. Overall, we accrued 197 patients (331 since inception ofthe SPORE) to these SPORE clinical trials. Studies of novel agents such as the mTOR inhibitor everolimus and the farnesyltransferase inhibitor tipifarnib have been completed and published. For everolimus, a new trial has been approved for NCCTG and combination trials of tipifarnib proposed. We also completed two trials using the immunostimulatory agent CpG. CpG will now be moved fonward in SPORE Project 2. During the last funding cycle, 2461 patients were enrolled into the MER for a cumulative total of 4562 patients. Seminal publications in the area of lymphoma epidemiology were reported en statins, vitamin D deficiency, and serum free light chains. In the area of molecular epidemiology, genetic variation in genes in immune response, coagulation, NFKB, and complement pathways were linked to lymphoma risk er prognosis. Over 45 manuscripts were published from activities in this core in this last funding period

UI/MC SPORE临床研究核心（CRC）的主要目标是成为直接的翻译链接 研究项目和这些项目产生的临床研究之间的关系。该委员会的具体目标 CRC将：1）协调和执行SPORE临床试验方案; 2）管理SPORE观察性研究 流行病学协议，并与分子流行病学资源（MER）合作。CRC提供了一个 临床研究与具体项目、核心和发展研究之间的关键环节。的 CRC由托马斯M.哈伯曼，医学博士，在马约诊所癌症中心和布赖恩林克，医学博士， 在霍尔顿综合癌症中心CRC的一个关键职能是协调发展 临床试验，协助患者招募，管理方案修订，报告不良事件， 适当的机构，并对临床试验数据提供全面的质量控制。对于MER， CRC同意新诊断的淋巴瘤患者，提取并输入临床和流行病学数据， 并系统地跟踪所有MER患者直至死亡。肿瘤组织和外周血血清、细胞， 由生物样本核心前瞻性收集、储存和跟踪的DNA和RNA与 CRC数据库。这为SPORE研究人员提供了淋巴瘤的综合和集中访问 研究项目。在上一个资助周期，启动或正在进行10项治疗性临床试验， 包括2个InterSPORE试验。总的来说，我们招募了197名患者（自SPORE成立以来有331名）， 这些孢子的临床试验新型药物如mTOR抑制剂依维莫司和抗肿瘤药物的研究 法尼基转移酶抑制剂tipifarnib已经完成并发表。对于依维莫司，一项新的试验 已被批准用于NCCTG和替吡法尼的联合试验。我们还完成了两项试验， 免疫刺激剂CpG。CpG现在将在SPORE项目2中向前移动。在过去 在资助周期内，2461例患者入组MER，累计4562例患者。开创性 淋巴瘤流行病学领域的出版物报告了他汀类药物、维生素D缺乏症和 血清游离轻链。在分子流行病学领域，免疫系统中基因的遗传变异 反应、凝血、NF κ B和补体途径与淋巴瘤风险或预后相关。超过 在上一个供资期内，该核心活动出版了45份手稿