The Clinical Core is designed to support all VICC breast cancer clinical trials conducted in the SPORE. Its main goals are: a) translate the latest insights of disease biology into rigorously designed SPORE clinical trials;b) streamline biologic sample collection in these clinical trials;c) minimize delays in the activation and promote timely completion of SPORE clinical trials;d) ensure safety of research subjects, adherence to institutional and federal regulatory requirements, and compliance with protocol-specified activities;and e) provide the expertise and manpower to develop, implement, manage and monitor all Breast Cancer SPORE clinical trials (internally and externally - multicentric trials). Over the course of this grant, the Clinical Core will support translational clinical trials coming from: two of the four main projects described in this grant application (projects 1 and 2), future pilot and career development projects, Inter-SPORE and inter-institutional collaborations, aligned with our SPORE. The Clinical Core will work closely with other SPORE Cores and the Clinical Trials Shared Resource of VICC to coordinate all aspects of clinical research, including imaging data extraction, biostatistics support, and biospecimen collection/ processing. The intensive nature of the clinical trials conducted by the SPORE (in terms of precisely timed interventions, the need for coordination of clinical intervention, radiological evaluation, specimen procurement, stabilization, and transport to the Pathology & Tissue Informatics Core, and the need to ensure protection of patients safety and privacy while linking clinical and specimen databases) must be tightly coordinated so that they are done on a consistent schedule, in a consistent fashion, to ensure that information obtained from one patient is comparable to data collected from all the others. Close coordination of clinical, administrative, and research staff activities are required to ensure that the responsibilities and costs for every element of the clinical trial are clearly defined and delineated. In summary, a Clinical Core focused on SPORE related clinical trials is essential for the success of the SPORE, and it has all resources available to achieve the aims outlined in the proposal.

Public Health Relevance

(See Instructions): The Clinical Core will be instrumental in increasing efficiency, minimizing delays and revisions, and maximizing our ability to conduct and complete clinical trials related to the SPORE. Streamlining the clinical trials process assures that these are conducted expeditiously and with the highest degree of scientific rigor, enhancing the SPORE's ability to provide translational research outcomes with tangible clinical benefit.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Specialized Center (P50)
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Special Emphasis Panel (ZCA1-RPRB-0)
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Vanderbilt University Medical Center
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