CC: Clinical Research

The Clinical Research Core is a newly created resource for the SPORE. It now combines the Patient Registry activities that have been ongoing and supported by the SPORE in the previous funding period with the new activities in the proposed funding period related to support for clinical studies in all four translational research projects. The directors of this Core have extensive experience in studies of human subjects and recruitment of patients to research protocols, both for observational studies and clinical trials. To date, the pancreatic cancer SPORE'S Patient Registry activities have been very productive, with accrual of 2279 consented subjects (~325/year), using ultra-rapid case finding, a necessary method for this rapidly fatal cancer. Mayo Clinic diagnoses and/or treats an estimated 570 pancreatic cancer patients per year across its three campuses. There are 1612 pancreatic cancer patients in the Registry, of which >50% have pancreatic tissue biospecimens accessioned in the Tissue Core. In addition, the Registry includes data on 1513 age, sex, race, and region-matched healthy controls. It will coordinate its activities very closely with the Biostatistics Core and the Tissue Core to ensure the highest quality annotated biospecimens and pancreatic cancer database for research. The infrastructure for patient recruitment in the Registry will be used to recruit subjects for Project 2. The SPORE will conduct early phase clinical trials in Projects 1, 3, and 4 in the next funding period. It will utilize the Cancer Center-supported Clinical Research Office (CRO) shared resource to operationalize the trials. The Clinical Research Core will 1) perform the necessary clinical trial management support activities; 2) centrally coordinate all activities with the infrastructure of the Cancer Center CRO to ensure smooth execution of the SPORE'S clinical trials; 3) perform all patient recruitment activities for the triple tracer test for Project 2; 4) recruit new onset diabetics to support the validation study in Project 2; 5) maintain the ultra-rapid case recruitment and registry of pancreatic cancer patients at all three Mayo campuses; and 6) serve as a resource to future developmental research and career development research projects. The close coordination and oversight of the most senior leaders of the SPORE will ensure that all clinical research activities are performed with the highest level of research integrity and adherence to all human subjects regulations.