Clinical Research

UI/MC孢子临床研究核心(CRC)的首要目标是成为直接的翻译链接 研究项目和由这些项目产生的临床研究之间的关系。《公约》的具体目标 CRC的职责是：1)协调和执行孢子临床试验方案；2)管理孢子观察 流行病学协议和分子流行病学资源(MER)的合作伙伴。CRC提供了一个 临床研究与特定项目、核心和发展研究之间的关键联系。这个 CRC由马里兰州梅奥诊所癌症中心的托马斯·M·哈伯曼和马里兰州布莱恩·林克共同指导， 在霍尔顿综合癌症中心。合作伙伴关系的一个关键职能是协调发展 临床试验，帮助患者积累，管理方案修改，报告不良事件TE 并为临床试验数据提供全面的质量控制。对于MER来说， 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患者的死亡过程。肿瘤组织和外周出血血清，细胞， 由生物谱系核心预期收集、存储和跟踪的DNA和RNA被链接到 CRC数据库。这为孢子调查人员提供了针对淋巴瘤的集成和集中访问 研究项目。在上一个供资周期中，启动或启动了10项治疗性临床试验， 包括2个SPORE试验。总体而言，我们收集了197名患者(自孢子诞生以来的331名) 这些孢子临床试验。MTOR抑制剂伊波利莫斯等新药的研究 法尼基转移酶抑制剂tipifarnib已经完成并发表。对于埃维洛莫斯，一项新的试验已经 已被批准用于NCCTG，并建议进行替法尼布的联合试验。我们还完成了两个试验，使用 免疫刺激剂CpG。CPG现在将在孢子项目2中被亲切地移动。在上一个 在资助周期中，2461名患者纳入MER，累计4562名患者。开创性 淋巴瘤流行病学领域的出版物报道了他汀类药物、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、NFKB和补体途径与淋巴瘤预后风险有关。完毕 在上一次供资期间，该核心活动出版了45份手稿

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