Improving the Processes around Approval, Accrual and Translational Research in Cancer Prevention Trials

ABSTRACT The central goal of this R50 Clinician Scientist Award application is to establish and refine processes that facilitate clinical trials in cancer interception at The University of Kansas Cancer Center (KUCC), a unique goal that is different from the majority of R50 applicants which focus on cancer treatment trials. Cancer prevention⎯renamed cancer interception, i.e., active rather than passive cancer prevention to disrupt cancer pathways early⎯is an NCI priority. The KUCC NCI-designated comprehensive cancer center is the regional leader for oncology care and its Cancer Prevention and Control (CPC) research program reorganized in 2019 has already had tremendous success; 69% of CPC members are principal investigators on funded cancer- related research grants, including 29% funded by the NCI. CPC members published 309 articles in 2022. I am a gastroenterologist and a physician-scientist with a focus on cancer prevention/interception. I joined KUCC in 2017 to build our gastrointestinal (GI) cancer prevention program, a major regional need, from ground up. The program has grown exponentially and now also serves as a conduit for accrual into cancer prevention, biomarker, and imaging trials. One such example is the 14-center NCI trial, “A Phase II Clinical Trial of the Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury) Vaccine (Tri-Ad5) in Lynch Syndrome (NCT05419011)” where I serve as the Lead PI and Study Chair. The KUCC Clinical Trials Office (CTO) has successfully supported cancer treatment trials, however many of the CTO’s processes for cancer interception trials can still be improved. Cancer interception trials have different challenges compared with cancer treatment trials because the patient population does not have active cancer and therefore does not interact directly with the cancer centers. Unlike treatment trials, these cancer prevention participants may not experience immediate benefits. Hence, the recruitment and retention strategy will need to be embedded within the clinical care structure which provides immediate value: the central idea behind my GI cancer prevention program. I propose to improve the KUCC CTO’s processes by: i) hiring project navigators to facilitate study approvals for the PIs in non-oncology departments, outside KUCC; ii) training research coordinators in prevention trials; iii) establishing processes for resource sharing between KUCC and non-oncology departments; iv) streamlining analysis of translational endpoints; v) improving minority recruitment via Juntos, a homegrown center to promote Latino health; and, vi) expanding the existing, “The Kansas Patients and Providers Engaged in Prevention Research (KPPEPR) Network” to improve access of underserved rural populations to cancer prevention trials. I will use my active participation in two NCI-supported Early Phase Clinical Cancer Prevention Consortia (Northwestern University and University of Michigan) to bring cancer prevention trials to KUCC and train junior faculty members to sustain the growth of this program. I have established relationships with leading investigators in the field to develop new research capabilities such as messenger RNA cancer vaccines for cancer interception.