Clinical Translational Core

项目总结

Project Summary Lung and prostate cancer together comprise a significant proportion of patients with cancer. These diseases are curable when detected early; however, when disease is advanced, more sophisticated ways to monitor response to therapy are clearly needed to make earlier decisions during the treatment course. The nanotechnologies developed in the CCNE-TD are well suited to advance early detection and therapeutic monitoring in lung and prostate cancer, with the potential to transform cancer care. The Clinical Translational Core (Core 2) team is comprised of a team of physicians and scientists with specific experience in developing new technologies for early detection and therapeutic monitoring in Prostate and Lung Cancers who are committed to moving nanotechnologies developed within the CCNE-TD into clinical application. Early input from clinical investigators in this Core will help avoid: (1) Development of technologies to study parameters of limited relevance to cancer; (2) Protocols with logistical or physical limitations that preclude eventual clinical translation; and (3) Delays in development because the proper clinical investigators, approvals and study staff have not been put in place (a process that can take 6 months to a year). Core 2 will assist project PIs to develop and implement a path for clinical translation with continuous support over the lifetime of the project, from early technology development, through pilot clinical testing, all the way to planning potential validation studies. The CCNE mechanism does not allow funding for prospective clinical trials. Nevertheless, the Clinical Translational Core will provide high quality specimens for pilot projects to bridge to other funded activities as well as apply for new funding for clinical trials to which we are whole-heartedly committed. Core 2 is dedicated to assisting each of the research project leaders achieve the following: 1) Identify internal and external sources of clinical specimens/patients to facilitate nanotechnology development; 2) Acquire material transfer agreements to receive clinical specimens 3) Obtain Institutional Review Board exemption or approval to use the nanotechnology in ex vivo samples 4) Provide antibodies and specimens to projects for pilot testing as required (Core 2 will secure access to 3 lung cancer and 2 prostate cancer clinical sample repositories, as well as 3 repositories that include additional cancer types); 5) Interface with external agencies including the NCI's Nanocharacterization Lab, and Food and Drug Administration for Investigational New Drug filings on behalf of project PI's for first-in-man studies; and 6) Consult on preparation of proposals for sources of clinical trial funding. Over the 5 years of CCNE-TD, we anticipate that Core 2 will distribute 6-8 custom antibodies or antibody fragments, >400 plasma or serum samples, >100 whole blood or fresh tissue samples, and >100 tumor specimens to our investigators. The Clinical and Translational Core will facilitate clinical implementation of CCNE-TD nanotechnologies and will contribute significantly to the center's overall success.