Clinical Trials Core

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。支持包括协助试验准备、监管问题、数据安全和监测、稽查、执行和报告。我们对肺癌分子基础的认识不断加深，这加强了继续开展研究的必要性，这些研究涉及收集临床数据和标本进行分子分析。这种翻译方法允许在人体组织中的肺癌发生的生物学途径的调查，并作为一个强大的工具，在评估新的策略，预防，筛查，早期检测和治疗肺癌。气候技术中心在翻译每个项目产生的科学成果方面发挥了重要作用。 由于我们试验的性质，CTC在科罗拉多孢子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，早期检测和组织获取，并有强大的招募和标本。试验受试者主要从附属医院的肺科诊所入组，癌症中心人员不在这些诊所。这些是尚未患肺癌的高风险受试者。此外，需要对每次访视时从每个程序中采集和处理大量标本进行专门培训。需要进行特殊处理，以便将诊断组织与残留组织分离，并进行细胞培养。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储存库数据库，用于管理与SPORE试验相关的生物标本的存储和检索。该数据库还跟踪所有SPORE研究对象，注册人数和人员，为赠款报告提供关键统计数据。NCI的生物信息学中心在Oracle Clinical中提供了我们的远程数据采集管理系统，这提供了一整套功能，以促进研究设计、数据输入、复制和差异管理。我们拥有一支经过专业培训的临床研究助理团队，负责为所有SPORE支持的试验招募受试者并收集数据/组织样本。所有数据都被输入到一个网络数据库中，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间，有9项试验得到了临床试验核心的支持，这些试验招募了720名受试者。正在根据基础科学和临床发现积极计划其他试验。在反恐中心的支持下，出版了34份涉及所有项目的出版物，并开展了多项纵向合作和随后的试验

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