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.
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