Core C - Clinical Research

核心 C - 临床研究

• 批准号: 9342679
• 负责人: Thomas odorisio
• 金额: $ 24.08万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9342679
• 关键词: 90Y; Adolescent; Adverse event; Amendment; Biological; Cells; Cessation of life; Child; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical trial protocol document; Collection; Comprehensive Cancer Center; Consent; DNA; Data; Databases; Development; Diagnosis; Distant Metastasis; Doctor of Philosophy; Enrollment; FDA approved; Family; Family member; Fruit; Future; G-Protein-Coupled Receptors; Genes; Genetic; Genetic Markers; Genetic screening method; Goals; Heart; Human; Image; Immunohistochemistry; Industry; Institution; Iowa; Isotope Therapy; Laboratories; Link; Long-Term Care; Malignant Neoplasms; Metastatic Neoplasm to the Liver; Molecular Target; Monitor; Neuroendocrine Tumors; New Agents; Newly Diagnosed; PET/CT scan; Pathologic; Pathway interactions; Patients; Peptide Receptor; Peptides; Performance; Population; Positron-Emission Tomography; Preparation; Prognostic Marker; Protocols documentation; Quality Control; Quality of life; RNA; Radiation therapy; Radionuclide therapy; Records; Recruitment Activity; Regional Disease; Registries; Reporting; Research; Research Personnel; Research Project Grants; Scientist; Serum; Specialized Program of Research Excellence; Specimen; Symptoms; System; Testing; Therapeutic Trials; Time; Tissue Microarray; Translational Research; Tumor Tissue; United States; Update; Visit; clinical development; clinical practice; design; diagnostic biomarker; disorder prevention; dosimetry; epidemiologic data; follow-up; imaging agent; member; metaiodobenzylguanidine; molecular pathology; neuroendocrine differentiation; novel diagnostics; patient population; peripheral blood; phase I trial; programs; prospective; theranostics; therapeutic target; treatment response; tumor registry

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.

爱荷华州神经内分泌肿瘤 SPORE 临床研究核心 (CRC) 的主要目标是 每个项目都将其科学研究成果带到临床终点，使患者双方受益 近期和将来。临床研究核心是研究之间的直接转化联系 项目以及这些项目产生的临床研究。 《核心》由托马斯·M·奥多里西奥 (Thomas M. O'Dorisio) 执导， 医学博士，丹尼尔·瓦埃纳 (Daniel Vaena) 医学博士和特里·布劳恩 (Terry Braun) 博士担任联合主任；这些董事均为 霍顿综合癌症中心。该核心的具体目标是： 1) 继续同意并将患者纳入爱荷华州神经内分泌肿瘤登记处，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SPORE临床试验方案。 CRC 将提供一个关键环节 临床研究与项目、核心和开发研究项目之间的关系； 3) 审查新的遗传、病理和影像测试的有效性并协调整合， 由项目开发，进入新的临床试验。 目标 1. CRC 获得新诊断和转诊的 NET 患者的同意，摘要并输入 临床和流行病学数据存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患者。肿瘤组织和外周血、血清、细胞、DNA和RNA 生物样本核心在 LabMatrix 中前瞻性地收集、存储和跟踪，以链接到 数据库。这为 NET 研究项目的 SPORE 研究人员提供了集成和集中的访问。 爱荷华州神经内分泌肿瘤诊所和登记处由 O'Dorisio 博士于 2000 年建立，拥有超过 1300 名患者 具有 NET 的受试者（和家庭成员）已同意此登记。目标 1 目标是继续 招募新患者参与注册并持续维护、更新和升级 支持注册表的数据库。定期输入每次就诊的患者数据。 目标 2. 爱荷华州 SPORE 调查员一直积极参与调查员发起的和 针对 NET 患者的 NCI 合作小组试验。这些试验包括成像和剂量测定 新靶向生物制品和肽受体放射性核素疗法（PRRT）的试验、治疗试验；和 唯一针对儿童和青少年的 PRRT 第一期试验。目标 2 中 CRC 的主要职能是协调 临床试验的开发、协助患者应计、管理 IRB 同意和修订 协议，向适当的机构报告不良事件，并提供全面的质量控制（例如 监控方案偏差和临床试验数据性能）。 目标 3. 根据审稿人的建议，CRC 将促进纳入 SPORE 的最新科学进展 进入 SPORE 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 免疫组织化学面板。 CRC 将指导和协助研究人员获得 FDA 批准新药 代理和测试。然后，CRC 将帮助将 FDA 批准的进展纳入临床实践。