NCI National Clinical Trials Network - Lead Academic Participant Sites

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Project Summary This grant will provide infrastructure support to the University of Colorado Consortium Cancer Center and its clinical care partner UCHealth to continue to support the specific aims of the grant:  To lead and participate in scientifically important and clinically relevant NCTN clinical trials.  To make these trials available to the greatest proportion of the cancer population of Colorado and Wyoming.  To rapidly activate, accrue, caringly provide patient coordination, and accurately report research related data in a timely way to the NCTN components responsible for conducting these trials.  To foster and develop young investigators in the NCTN process. Specific support is requested for the administrative, regulatory, clinical coordination, and data management needs to conduct clinical trials of the NCTN safely and efficiently on behalf of the cancer patients in Colorado and our wider catchment area. In addition, we will support enhanced monitoring and auditing to ensure patient safety and proper conduct of the trials at all our sites of clinical care. Quality assessment and improvement are a central features of our NCTN program. We take seriously the mandate to participate in the development of new concepts, the contribution of our laboratory scientists in these translational projects, and the fostering of new junior investigators to further the clinical impact of therapeutic trials in the NCTN. Dialog and communication are key. Within our institution, we have created a superb forum for our investigators across the entire system (the LAPS Executive Committee) that represents all modalities and disease-oriented groups to prioritize and commit to new trials, to monitor accrual and any other issues related to the conduct of these trials across our system. We support travel for investigators, staff, and scientists to participate in the NCTN meetings and committees. A new initiative will be supported with this grant. Many of the new trials are multi-oncologic, and/or require molecular characterization of the patient's tumor to match the patient to appropriate treatment protocols. Our institution already has a “T3” CRA team to handle multi-oncologic “basket” trials, and we have a fully functional Molecular Tumor Board. In separate efforts, we are developing patient-specific molecular databases that will obtain both internal and external molecular tumor data, and will be searchable. A navigator position to regularly review these databases, the molecularly-driven clinical trials, and guide patients and clinicians to match the patients to the suitable trials may improve our accrual to these trials.