Clinical Trials

临床试验核心将提供制定、实施和协调 在Gl孢子中进行的临床转化研究试验。最终目标是开发改进的 通过更好地了解以下方面为患有或有患胃肠道癌症风险的患者提供治疗 这些癌症的生物学。为了实现这一目标，临床试验核心的主要责任将是 1)提供与以下相关的转化性临床试验的开发和实施方面的专业知识 孢子项目；2)保证和维持患者参与孢子发起的试验的足够收益； 3)为这些临床试验提供研究护士、数据管理员和样本采购支持；4) 监督和确保研究对象的安全，遵守机构和联邦法规 要求，并遵守协议规定的活动；5)监督及时和准确的录入 数据存入OnCore数据库。在之前的赠款期间，临床试验核心提供了 支持四项治疗性临床试验，在Vanderbilt获得了65名研究患者和142名患者 总体而言，还有一项流行病学研究，田纳西州大肠息肉研究，纳入了3744名患者。 核心小组的努力在协调与东部合作社联合开展的一项研究方面起到了关键作用 肿瘤学组，从全组登记的25%的患者中获得配对的肿瘤活检组织，并 在范德比尔特大学登记的19名患者中有18名(95%)。在竞争的更新中，临床试验的核心将 项目1中包括的支持试验包括联合阻断晚期糖尿病患者的EGFR轴 1-2年的结直肠癌和联合使用EGFR-和Src-Kinase抑制剂作为新的辅助药物 结直肠癌和潜在可切除肝转移患者的治疗2-4年， 项目2是一种调节E-钙粘附素的先导化合物，项目4是田纳西州大肠息肉研究。 从这些试验中获得的知识和见解将被用来设计后续试验，以便在 这种孢子，并在适当的情况下，协助开展更大规模的验证性试验。 作为孢子间或合作群体的合作。

The Clinical Trials Core will provide expertise in the development, implementation and coordination of the clinical translational research trials performed in the Gl SPORE. The ultimate goal is to develop improved therapies for patients with or at risk of developing gastrointestinal cancers through a better understanding of the biology of those cancers. To achieve this goal, the major responsibilities of the Clinical Trials Core will be to 1) provide expertise in the development and implementation of translational clinical trials related to the SPORE projects; 2) assure and maintain adequate accrual of patients to participate in SPORE-initiated trials; 3) provide research nurse, data manager; and specimen procurement support for these clinical trials; 4) monitor and assure the safety of research subjects, adherence to institutional and federal regulatory requirements, and compliance with protocol-specified activities; and 5) overseethe timely and accurate entry of data into the OnCore database. During the previous grant period, the Clinical Trials Core provided support for four therapeutic clinical trials that accrued 65 study patients at Vanderbilt and 142 patients overall, and one epidemiologic study, the Tennessee Colorectal Polyp Study, which enrolled 3744 patients. The core's efforts were pivotal in coordinating a study performed in conjunction with the Eastern Cooperative Oncology Group in which paired tumor biopsies were obtained from 25% of patients enrolled group-wide and in 18 of 19 (95%) patients enrolled at Vanderbilt. In the competing renewal, the Clinical Trials Core will support trials included in Project 1 including combined blockade of the EGFR axis in patients with advanced colorectal cancer during Years 1-2 and combined use of EGFR- and Src-kinase inhibitors as neoadjuvant therapy in patients with colorectal cancer and potentially resectable liver metastases during Years2-4, Project 2 of a lead compound to modulate E-cadherin, and Project 4, the Tennessee Colorectal Polyp Study. Knowledge and insights gained from these trials will be used to design follow-up trials to be conducted within this SPORE and, when appropriate, assist in the development of larger, confirmatory trials to be conducted as inter-SPORE or cooperative group collaborations.