Clinical Trials Core

临床试验核心

• 批准号: 9369733
• 负责人: Robert Keith
• 金额: $ 28.37万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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/9369733
• 关键词: American College of Radiology Imaging Network; Basic Science; Bioinformatics; Biological; Biological Markers; Biopsy; Breath Tests; Cancer Center; Cancer Hospital; Cancer Patient; Chemoprevention; Clinic; Clinical; Clinical Cancer Center; Clinical Data; Clinical Research Associate; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Colorado; Consent; Correlative Study; Cytology; DNA Sequence Alteration; Data; Databases; Diagnostic; Diagnostic tests; Early Diagnosis; Eligibility Determination; Enrollment; Epidemiology; Evaluation; Exhalation; Funding; Future; Genes; Goals; Grant; Hand; Hospitals; Human; Human Resources; Individual; Industry; Internet; Investigation; Laboratories; Laboratory Finding; Link; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Maps; Methylation; Molecular; Molecular Analysis; Monitor; Nature; Pathway interactions; Patients; Phase; Play; Preparation; Prevention; Prevention strategy; Principal Investigator; Procedures; Protocols documentation; Publications; Reporting; Research Design; Research Infrastructure; Research Personnel; Resources; Retrieval; Risk; Role; Safety; Sampling; Science; Scientist; Site; Southwest Oncology Group; Specimen; Study Subject; System; Therapeutic; Therapeutic Intervention; Therapeutic Trials; Tissue Banks; Tissue Sample; Tissues; Training; Translating; Translational Research; Translations; Tyrosine Kinase Inhibitor; Visit; base; biobank; biomarker development; biomarker-driven; cancer risk; clinical application; clinical investigation; companion diagnostics; crizotinib; database design; design; electronic data; high risk; human subject; human tissue; innovation; lung carcinogenesis; novel; novel strategies; personalized therapeutic; programs; promoter; relational database; resistance mechanism; screening; statistics; tissue biomarkers; tissue/cell culture; tool; translational approach; trial design

The goal of the Clinical Trials Core (CTC) is to provide support for clinical trials designed and implemented for SPORE projects. The support includes assistance with trial preparation, regulatory issues, data safety and monitoring, auditing, conduct, and reporting. Our increasing understanding of the molecular basis of lung cancer has reinforced the need to continue conducting studies which involve the collection of both clinical data and specimens for molecular analyses. This translational approach allows for the investigation of biological pathways of lung carcinogenesis in human tissue, and acts as a powerful tool in the evaluation of novel strategies for the prevention, screening, early detection, and treatment of lung cancer. The CTC has been essential in translating the science generated from each of the individual projects. The CTC has played a crucial role in the Colorado SPORE due the nature of our trials. Our trials have largely focused on chemoprevention, early detection, and tissue acquisition, and have robust enrollments and specimens. Trial subjects are predominantly enrolled from pulmonary clinics at affiliated Hospitals where Cancer Center personnel are not located. These are high risk subjects who do not yet have lung cancer. In addition, specialized training is required for the collection and handling of large numbers of specimens from each procedure at each visit. Special processing to allow separation of diagnostic tissue from remnant tissue and for cell culture is required. The Clinical Trials Core utilizes two databases. The SPORE Bioinformatics core provides a biorepository database that manages the storage and retrieval of biospecimens related to SPORE trials. This database also tracks all SPORE study subjects, enrollments, and personnel providing key statistics for grant reporting. The NCl's Center for Bioinformatics provided our remote data capture management system in Oracle Clinical, and this provides a full suite of capabilities to facilitate study design, data entry, replication, and discrepancy management. We have a team of clinical research associates expertly trained to accrue subjects and collect data/tissue samples for all SPORE-supported trials. All data is entered into a web database designed to link the clinical information to the biological correlative studies for future analyses. During the previous five year funding period there have been 9 trials supported by the Clinical Trials Core and these trials have enrolled 720 subjects. Additional trials are being actively planned based on basic science and clinical discoveries. The CTC support has led to 34 publications involving all of the projects and to multiple vertical collaborations and subsequent trials

临床试验核心 (CTC) 的目标是为 SPORE 项目设计和实施的临床试验提供支持。支持包括试验准备、监管问题、数据安全和监控、审计、实施和报告方面的协助。我们对肺癌分子基础的日益了解加强了继续进行研究的必要性，这些研究涉及收集临床数据和样本进行分子分析。这种转化方法可以研究人体组织中肺癌发生的生物学途径，并可作为评估肺癌预防、筛查、早期检测和治疗新策略的有力工具。 CTC 在转化每个项目产生的科学成果方面发挥着至关重要的作用。 由于我们试验的性质，CTC 在科罗拉多 SPORE 中发挥了至关重要的作用。我们的试验主要集中在化学预防、早期检测和组织采集，并且有大量的入组和样本。试验受试者主要从癌症中心人员不在的附属医院的肺部诊所招募。这些是尚未患肺癌的高危人群。此外，每次就诊时，需要对每个程序中大量标本的收集和处理进行专门培训。需要进行特殊处理以将诊断组织与残余组织分离并用于细胞培养。临床试验核心使用两个数据库。 SPORE 生物信息学核心提供了一个生物存储数据库，用于管理与 SPORE 试验相关的生物样本的存储和检索。该数据库还跟踪所有 SPORE 研究主题、注册情况和人员，为拨款报告提供关键统计数据。 NCl 的生物信息学中心在 Oracle Clinical 中提供了远程数据采集管理系统，这提供了促进研究设计、数据输入、复制和差异管理的全套功能。我们拥有一支经过专业培训的临床研究人员团队，可以为所有 SPORE 支持的试验招募受试者并收集数据/组织样本。所有数据都输入到网络数据库中，该数据库旨在将临床信息与生物相关研究联系起来以供将来分析。在过去的五年资助期内，临床试验核心支持了 9 项试验，这些试验已招募了 720 名受试者。根据基础科学和临床发现，正在积极计划更多试验。 CTC 的支持导致了涉及所有项目的 34 篇出版物以及多个纵向合作和后续试验