Core C - Clinical Research

爱荷华州神经内分泌肿瘤孢子临床研究核心(CRC)的主要目标是使 每个项目将其科学研究成果带到临床终点，使患者既受益于 在最近和未来。临床研究核心是研究之间的直接转换链接 由这些项目产生的项目和临床研究。《核心》由托马斯·M·奥多里西奥执导， 医学博士、医学博士Daniel Vaena和博士Terry Braun为联席董事；这些董事都是 霍尔顿综合癌症中心。这一核心的具体目标是： 1)继续同意并将患者纳入爱荷华州神经内分泌肿瘤注册中心，并 进一步开发爱荷华州神经内分泌肿瘤数据库 2)协调和执行孢子临床试验方案。《儿童权利公约》将提供一个关键环节 临床研究与项目、核心和发展研究项目之间的关系； 3)审查和协调新的遗传、病理和成像测试的有效性； 由项目开发，进入新的临床试验。 目的1.儿童权利中心征得新诊断和转介的NETS患者的同意，提取并进入 临床和流行病学数据输入神经内分泌肿瘤数据库(RedCap)，并系统地 通过死亡来管理和治疗病人。肿瘤组织和外周血液、血清、细胞、DNA和RNA 由Biosecimens Core前瞻性地收集、存储和跟踪到LabMatrix中，以便与 数据库。这为网络研究项目提供了对孢子调查员的综合和集中访问。 爱荷华州神经内分泌肿瘤诊所和登记处是由奥多里西奥博士于2000年建立的，至今已有1300多人 母语英语教师的受试者(及家庭成员)已获本登记处同意。目标1目标是继续 招募新患者加入登记处，并持续维护、更新和升级 支持注册表的数据库。每次就诊的患者数据都会定期输入。 目标2.爱荷华州孢子调查员一直积极参与设计和实施由调查员发起的 NCI针对NETs患者的合作团体试验。这些试验包括成像和剂量测定。 新的靶向生物制品和多肽受体放射性核素疗法的试验、治疗试验；以及 仅对儿童和青少年进行PRRT的I期试验。目标2中《儿童权利公约》的主要职能是协调 临床试验的开发，帮助患者积累，管理IRB同意和修改 方案，向适当的机构报告不良事件，并提供全面的质量控制(例如 监测方案偏差和临床试验数据性能)。 目标3.根据审查者的建议，儿童权利委员会将促进纳入最新的科学孢子进展 进入孢子临床试验。项目1、2、3和4准备开发新的显像剂、基因测试和 免疫组织化学小组。儿童权利委员会将指导和协助调查人员获得FDA对新的 代理和测试。然后，CRC将协助将FDA批准的进展纳入临床实践。

The Iowa Neuroendocrine Tumor SPORE Clinical Research Core (CRC) has, as its primary goal, to enable each project to bring the fruit of its scientific research to a clinical end point that will benefit patients both proximally and in the future. The Clinical Research Core is the direct translational link between research projects and clinical research emanating from these projects. This Core is directed by Thomas M. O'Dorisio, MD, with Daniel Vaena, MD, and Terry Braun, PhD, as co-directors; these directors are all members of the Holden Comprehensive Cancer Center. The specific aims of this Core are to: 1) Continue to consent and enroll patients into the Iowa Neuroendocrine Tumor Registry and to further develop the Iowa Neuroendocrine Tumor Database 2) Coordinate and perform SPORE clinical trials protocols. The CRC will provide a critical link between clinical research and the projects, cores, and developmental research projects; 3) Review validity of and coordinate incorporation of new genetic, pathologic, and imaging tests, developed by Projects, into new clinical trials. Aim 1. The CRC obtains consent from newly diagnosed and referred patients with NETs, abstracts and enters clinical and epidemiologic data into the Neuroendocrine Tumor Database (REDCap), and systematically manages and treats patients through death. Tumor tissue and peripheral blood, serum, cells, DNA, and RNA are prospectively collected, stored and tracked in LabMatrix" by the Biospecimens Core for linkage to the database. This provides integrated and centralized access to SPORE investigators for NET research projects. The Iowa Neuroendocrine Tumor Clinic and Registry were established by Dr. O'Dorisio in 2000 and over 1300 subjects (and family members) with NETs have been consented to this Registry. Aim 1 goals are to continue to recruit new patients to participate in the Registry and to continually maintain, update, and upgrade the databases that support the Registry. Patient data from each visit is entered regularly. Aim 2. Iowa SPORE investigators have been active in design and conduct of both investigator-initiated and NCI cooperative group trials for patients with NETs. These trials have encompassed imaging and dosimetry trials, therapeutic trials of new targeted biologicals and peptide receptor radionuclide therapy (PRRT); and the only Phase I trial of PRRT for children and adolescents. Key functions of the CRC in Aim 2 are to coordinate the development of clinical trials, assist in patient accrual, manage IRB consents and amendments for protocols, report adverse events to appropriate agencies, and provide comprehensive quality control (e.g. monitor for protocol deviations & clinical trial data performance). Aim 3. As suggested by reviewers, the CRC will facilitate incorporation of recent scientific SPORE advances into SPORE clinical trials. Projects 1, 2, 3, and 4 are poised to develop new imaging agents, genetic tests, and immunohistochemistry panels. The CRC will guide and assist investigators in obtaining FDA approval for new agents and tests. CRC will then aide in incorporation of FDA approved advances into clinical practice.