Core C - Clinical Research

核心 C - 临床研究

• 批准号: 8850622
• 负责人: Thomas odorisio
• 金额: $ 22.91万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8850622
• 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; Institutional Review Boards; 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; abstracting; clinical practice; design; disorder prevention; dosimetry; epidemiologic data; follow-up; imaging agent; member; metaiodobenzylguanidine; molecular pathology; novel diagnostics; patient population; peripheral blood; phase I trial; programs; 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孢子临床研究中心（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，使患者受益， 近距离和未来。临床研究核心是研究之间的直接翻译联系 项目和临床研究从这些项目中产生。这个核心是由托马斯M。奥多里西奥 医学博士，丹尼尔维纳，医学博士和特里布劳恩，博士，作为共同主任;这些董事都是成员的 霍尔顿综合癌症中心。该核心的具体目标是： 1)继续签署知情同意书并将患者入组爱荷华州神经内分泌肿瘤登记研究， 进一步开发爱荷华州神经内分泌肿瘤数据库 2)协调并执行SPORE临床试验方案。CRC将提供一个关键链接， 临床研究与项目、核心和发展研究项目之间的关系; 3)审查新的遗传学、病理学和影像学检查的有效性和协调整合， 由Projects开发，用于新的临床试验。 目标1. CRC获得新诊断和转诊的NET患者的同意，摘要并输入 将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、血清、细胞、DNA和RNA 由生物样本核心在LabMatrix中前瞻性收集、储存和跟踪， 数据库这为NET研究项目提供了对SPORE调查人员的集成和集中访问。 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， 以英语为母语的受试者（及其家庭成员）已同意参加本资料库。目标1：继续 招募新患者参与登记研究，并持续维护、更新和升级 支持注册表的数据库。定期输入每次访视的患者数据。 目标二。爱荷华州SPORE调查人员一直积极参与设计和实施这两个由发电机启动的， NCI对NET患者的合作组试验。这些试验包括成像和剂量测定 试验，新靶向生物制剂和肽受体放射性核素治疗（PRRT）的治疗试验;以及 唯一一项针对儿童和青少年的PRRT I期试验。在目标2中，CRC的主要职能是协调 临床试验的开发，协助患者招募，管理IRB同意书和修订， 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， 监测方案偏离和临床试验数据性能）。 目标3.正如评审员所建议的那样，CRC将促进纳入最新的科学进展 进入孢子临床试验项目1、2、3和4准备开发新的成像剂、基因测试和 免疫组织化学板。CRC将指导并协助研究者获得FDA批准， 代理和测试。然后，CRC将协助将FDA批准的进展纳入临床实践。