Core D: Clinical

摘要：核心D：临床研究。孢子临床研究核心(CRC)是其首要目标 成为研究项目和临床研究之间的直接翻译纽带，这些研究项目和临床研究 项目。儿童权利中心由临床试验单位和分子流行病学资源(MER)组成。 具体目标是：1)协调和执行孢子临床试验方案；2)管理孢子 观察流行病学方案和与MER的合作伙伴。CRC在以下方面提供了关键的联系 临床研究和具体的项目、核心和开发研究。启联中心由署长领导， 托马斯·M·哈伯曼，医学博士，梅奥诊所癌症中心，医学博士，布莱恩·林克，医学博士， 霍尔顿综合癌症中心。临床研究中心的一个重要职能是协调临床的发展。 试验，协助患者积累，管理方案修改，向适当机构报告不良事件， 并对临床试验数据提供全面的质量控制。对于MER，中国儿童基金会新同意 确诊的淋巴瘤患者，提取并输入临床和流行病学数据，并系统地跟踪 所有的病人都活到死了。CRC与提供孢子调查的其他孢子核心相关联 项目一体化、集中化接入。 在上一个资助周期中，儿童权利委员会非常活跃，有5项试验积极吸引患者，4项新试验 启动了治疗试验；总共有161名患者参加了这些孢子试验。新型制剂的研究 如mTOR抑制剂伊维洛莫斯已完成并发表，并被转移到与R- CHOP在联盟国家临床试验网络小组中取得了令人振奋的结果。两个试验使用 免疫刺激剂CpG已完成，CpG现已纳入项目2的一项新试验。 在上一个资助周期(截至2015年6月)，2391名新患者加入了MER(累计总数 7605例)。正电子发射计算机断层扫描/CT监视扫描实用领域的开创性、改变实践的出版物 弥漫性大B细胞淋巴瘤(DLBCL)--一种预测长期生存的新的早期终点无事件生存(EFS24) 术语DLBCL结局和滤泡性淋巴瘤(FL)在利妥昔单抗时代的转化都起源于 CRC研究。CRC还为淋巴瘤的大型全基因组关联研究做出了贡献，临床 观察到体重指数、补充替代药物和反式脂肪酸摄入量和风险 据报道。在过去的四年里，涉及这个核心的活动已经出版了86篇手稿 资助期。CRC已经与每个项目共同负责人合作，计划新的临床试验 包括在项目1-3中，并在项目4中继续使用MER。儿童权利委员会还将与 任何临床或生物标记物试验的发展研究项目和职业提升计划。 儿童基金会对孢子的成功至关重要，并期待着继续为孢子服务。 下一笔拨款中的调查人员。

ABSTRACT: Core D: Clinical Research. The 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 CRC is composed of the Clinical Trials Unit and the Molecular Epidemiology Resource (MER). The specific aims are to: 1) coordinate and perform SPORE clinical trial protocols; 2) manage SPORE observational epidemiology protocols and partner with the MER. The CRC provides a critical link between clinical research and the specific projects, cores, and developmental research. The CRC is led by the Director, Thomas M. Habermann, MD, at the Mayo Clinic Cancer Center and a Co-Director 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 to 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. The CRC is linked to other SPORE cores providing SPORE investigators integrated and centralized access for projects. During the last funding cycle the CRC has been very active with 5 trials actively accruing patients and 4 new therapeutic trials initiated; overall 161 patients were accrued to these SPORE trials. Studies of novel agents such as the mTOR inhibitor everolimus were completed and published and moved to combinations with R- CHOP in the ALLIANCE National Clinical Trials Network group with promising results. Two trials using the immunostimulatory agent CpG were completed with CpG now incorporated into a new trial in Project 2. During the last funding cycle (through June, 2015), 2391 new patients were enrolled into the MER (cumulative total 7605 patients). Seminal, practice-changing publications in the areas of utility of PET/CT surveillance scans in diffuse large B-cell lymphoma (DLBCL), a new early endpoint - event-free survival (EFS24) for predicting long term DLBCL outcome, and transformation of follicular lymphoma (FL) in the rituximab era all originated from CRC research. The CRC also contributed to large genome-wide association studies in lymphoma, clinical observations in body mass index, complementary alternative medicine and trans fatty acid intake and risk were reported. 86 manuscripts have been published from activities involving this core in the last 4 years of this funding period. The CRC has worked with each of the Project Co-Leaders to plan the new clinical trials included in Projects 1-3 and continued use of the MER in Project 4. The CRC will also work with recipients of the Developmental Research Projects and Career Enhancement Program on any clinical or biomarker trials. The CRC has been vital to success of the SPORE and looks forward to continuing to serve SPORE investigators in the next grant.