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孢子临床研究核心（CRC）作为其主要目标，以实现 每个项目都将其科学研究的果实带到临床终点，这将使患者受益 近端和将来。临床研究核心是研究之间的直接翻译联系 这些项目发出的项目和临床研究。该核心由Thomas M. O'Dorisio执导， 医学博士，与医学博士Daniel Vaena和博士的Terry Braun一起担任联合主任；这些董事都是 霍顿综合癌症中心。该核心的具体目的是： 1）继续同意并招募患者进入爱荷华州神经内分泌肿瘤注册表和 进一步发展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。 CRC将提供关键链接 在临床研究与项目，核心和发展研究项目之间； 3）回顾新遗传，病理和成像测试的有效性和坐标掺入的有效性， 由项目开发成新的临床试验。 AIM1。CRC从已诊断和推荐的网络，摘要和Enters的患者获得同意 临床和流行病学数据进入神经内分泌肿瘤数据库（REDCAP），并系统地 通过死亡管理并治疗患者。肿瘤组织和外周血，血清，细胞，DNA和RNA 被前瞻性地收集，存储和跟踪在Labmatrix中”，由Biospecimens Core链接到 数据库。这为净研究项目提供了综合和集中式访问孢子研究人员的访问权限。 爱荷华州神经内分泌肿瘤诊所和注册表由O'Dorisio博士于2000年建立，超过1300 具有网络的受试者（和家庭成员）已同意此注册表。目标1目标是继续 招募新患者参加注册表，并不断维护，更新和升级 支持注册表的数据库。每次访问的患者数据定期输入。 AIM2。爱荷华州孢子调查人员一直在研究和行为的研究和行为。 NCI净患者的NCI合作组试验。这些试验包括成像和剂量测定法 试验，新靶向生物学和肽受体放射性核素治疗（PRRT）的治疗试验；和 只有PRRT对儿童和青少年的I期试验。 AIM 2中CRC的关键功能是协调 开发临床试验，协助患者应计，管理IRB同意和修正案 协议，向适当机构报告不良事件，并提供全面的质量控制（例如 监控协议偏差和临床试验数据性能）。 AIM 3。正如审稿人所建议的那样，CRC将促进近期科学孢子进展 进入孢子临床试验。项目1、2、3和4准备开发新的成像剂，基因测试和 免疫组织化学面板。 CRC将指导并协助调查人员获得FDA批准 代理和测试。然后，CRC将帮助将FDA批准的进步纳入临床实践。