Clinical Trials

临床试验核心将提供开发、实施和协调 在GI SPORE进行的临床转化研究试验。最终目标是开发更好的 通过更好地了解胃肠道癌患者或有发生胃肠道癌风险的患者的治疗方法， 这些癌症的生物学。为了实现这一目标，临床试验中心的主要职责将 是1）在开发和实施与以下相关的转化临床试验方面提供专业知识： SPORE项目; 2）确保并维持足够的患者参与SPORE发起的试验; 3)为这些临床试验提供研究护士、数据管理员和标本采购支持; 4） 监测并确保研究受试者的安全，遵守机构和联邦法规 要求，并遵守方案规定的活动;和5）监督及时和准确的输入 将数据导入OnCore数据库在上一个赠款期间，临床试验核心提供了 支持四项治疗性临床试验，其中范德比尔特有65名研究患者， 以及一项流行病学研究，田纳西州结直肠息肉研究，该研究招募了3744名患者。 核心小组的努力在协调与东部合作社联合进行的一项研究方面发挥了关键作用。 肿瘤学组，从全组25%的入组患者中获得配对肿瘤活检， 在范德比尔特入组的19例患者中有18例（95%）。在竞争性更新中，临床试验核心将 项目1中纳入的支持性试验，包括在晚期乳腺癌患者中联合阻滞EGFR轴 第1-2年期间的结直肠癌以及EGFR和Src激酶抑制剂联合使用作为新辅助治疗 在2 -4年期间，在患有结直肠癌和可能可切除的肝转移的患者中进行治疗， 项目2：调节E-钙粘蛋白的先导化合物，项目4：田纳西结直肠息肉研究。 从这些试验中获得的知识和见解将用于设计后续试验， 该SPORE，并在适当时协助开展更大规模的验证性试验 作为孢子间或合作组协作。

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.