Clinical Research

The UI/MC SPORE Clinical Research Core (CRC) has as its primary goal to be the direct translational link between research projects and clinical research emanating from these projects. The specific aims of the CRC are to: 1) coordinate and perform SPORE clinical trials protocols; 2) manage SPORE observational epidemiology protocols and partner with the Molecular Epidemiology Resource (MER). The CRC provides a critical link between clinical research and the specific projects, cores, and developmental research. The CRC is co-directed by Thomas M. Habermann, MD, at the Mayo Clinic Cancer Center and Brian Link, MD, at the Holden Comprehensive Cancer Center. A key function of the CRC is to coordinate the development of clinical trials, assist in patient accrual, manage protocol amendments, report adverse events te appropriate agencies, and provide comprehensive quality control on clinical trial data. For the MER, the CRC consents newly diagnosed lymphoma patients, abstracts and enters clinical and epidemiologic data, and systematically follows all MER patients through death. Tumor tissue and peripheral bleed serum, cells, DNA, and RNA that are prospectively collected, stored and tracked by the Biospecimens Core are linked to the CRC database. This provides SPORE investigators integrated and centralized access for lymphoma research projects. During the last funding cycle, 10 therapeutic clinical trials were initiated or active, including 2 InterSPORE trials. Overall, we accrued 197 patients (331 since inception ofthe SPORE) to these SPORE clinical trials. Studies of novel agents such as the mTOR inhibitor everolimus and the farnesyltransferase inhibitor tipifarnib have been completed and published. For everolimus, a new trial has been approved for NCCTG and combination trials of tipifarnib proposed. We also completed two trials using the immunostimulatory agent CpG. CpG will now be moved fonward in SPORE Project 2. During the last funding cycle, 2461 patients were enrolled into the MER for a cumulative total of 4562 patients. Seminal publications in the area of lymphoma epidemiology were reported en statins, vitamin D deficiency, and serum free light chains. In the area of molecular epidemiology, genetic variation in genes in immune response, coagulation, NFKB, and complement pathways were linked to lymphoma risk er prognosis. Over 45 manuscripts were published from activities in this core in this last funding period.