Early Phase Clinical Cancer Prevention Consortium

Early Phase Clinical Cancer Prevention Consortium (ClinCaP) The ClinCaP consortium engages basic, translational and clinical investigators in both scientific discovery and clinical research to develop trials targeting the reversal of obesity-induced pathways that support increased cancer stem cell pools and result in increased cancer risk. As a new consortium, we established an Operations Committee consisting of strong leaders in clinical cancer prevention research with specific areas of expertise in breast, colorectal, esophageal, and genitourinary cancers that we now expand to include endometrial cancers and genomic risk factors. These experienced leaders establish collaborative Working Groups that include a broad range of investigators from both clinical and basic sciences to guide new translational research, clinical trial concept development and the integration of evolving laboratory capabilities for biomarker assessment as we move forward. The Working Groups provide a scientific forum for evaluating candidate agents, trial designs, factors that impact on trial accrual, and selection of optimal, mechanism-based endpoints to target. The ClinCaP has a robust scientific pipeline of novel trial concepts and currently operates 10 early phase prevention trials, including three collaborative inter-consortium trials. ClinCaP has expanded from 11 to 13 Affiliated Organizations (AOs), all funded by NCI comprehensive cancer center core grants, to meet the scientific objectives of operating our trials. We propose four aims. First, we will submit 1-3 new concepts/year to CP-CTNet by: 1) utilizing the scientific interactions within the Working Groups to facilitate development of new trial concepts, and 2) providing comprehensive support for the development of trial concepts and protocols including statistical expertise for trial design, internal scientific review, input from community-based patient advocates, and multi-site coordinating staff for protocol development. Second, the Operations Committee will work to engage and mentor early-stage investigators for concept and trial development. Third, we expand our working groups to include endometrial and genomic risk groups to better address our scientific priorities. Fourth, we will operate 2-4 approved trials each year, accruing at least 40 participants per year, in a manner compliant with CP-CTNet procedures, all regulatory requirements, and laboratory practices that assure high quality samples for research on the biology of early neoplasia. Overall, the scientific breadth and strong academic accomplishments of our consortium permit deep intellectual engagement. Combined with our experienced logistics of trial conduct, this allows for paradigm shifts in trial designs as we work to develop new approaches for cancer prevention.