EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-030) ABSTRACT The Early Phase Clinical Research Support (EPCRS) component provides data management support to conduct novel early-phase clinical trials designed from research findings of UCCC members. The overall objective of the EPCRS is to promote innovative clinical trials in the UCCC catchment area (the State of Colorado), to facilitate inter- and intra-programmatic translational collaboration within UCCC, and to support the development of novel cutting-edge therapies and strategies to prevent and treat cancer. These clinical trials are hypothesis-driven, high-priority, innovative, Pilot (feasibility) or Phase 0/I institutional trials focused on early phase testing of an agent or device for the diagnosis, prevention, detection or treatment of cancer. Expected outcomes include subsequent later stage clinical testing through the National Clinical Trials Network (NCTN), the Phase II mechanism of the Experimental Therapeutics Clinical Trials Network (ET-CTN), or in conjunction with independent peer-reviewed grant support or industry funding. Although EPCRS was not funded over the last cycle due to disapproval of our PRMS, UCCC has continued to conduct early phase trials which adhere to the NCI eligibility requirements of this mechanism and through our NCI UM1 Southwest Early Clinical Trials (SECT) Consortium (UM1CA186688) with MD Anderson Cancer Center, as well as institutional and industry support, funding has been available to translate bench observations made by our translational UCCC members, to the bedside. Going forward a number of changes have been instituted to further ensure that only the highest quality early clinical science is carried out at UCCC. These include an Investigator-Initiated Trial (IIT) structure, that includes an IIT Incubator (IIT-I) meeting chaired by Eckhardt that brings together a multidisciplinary group of investigators to discuss and promote hypothesis-driven early trials, as well as an IIT Review Committee (IIT-RC) chaired by Flaig and Eckhardt that is charged with ensuring that all components of a concept such as the scientific rationale, statistics, data management, budgeting and finance are assembled to enhance feasibility and to enable prioritization for funding decisions. In addition to the requested CCSG funds, UCCC will provide $250K/yr for early-phase clinical trials that will facilitate expansion of IITs and provide greater opportunity for the translational science of UCCC programs to impact patients in our catchment area. Our future directions include: 1) Establishing processes that stimulate direct collaborations between the UCCC clinical disease groups and the UCCC Research Programs; 2) Working with preclinical scientists in the UCCC to enable the development of novel animal models that can be used provide the rationale for hypothesis-driven early clinical trials; 3) Evaluating challenges regarding participation among racial/ethnic and socioeconomically underserved populations in early clinical trials; 4) Interacting with major UCCC wide strategic initiatives that involve early clinical investigation.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA046934-30
Application #
9429060
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2018-02-01
Budget End
2019-01-31
Support Year
30
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of Colorado Denver
Department
Type
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
Kim, Seongsoon; Park, Donghyeon; Choi, Yonghwa et al. (2018) A Pilot Study of Biomedical Text Comprehension using an Attention-Based Deep Neural Reader: Design and Experimental Analysis. JMIR Med Inform 6:e2
Altieri, Lisa; Miller, Kimberly A; Huh, Jimi et al. (2018) Prevalence of sun protection behaviors in Hispanic youth residing in a high ultraviolet light environment. Pediatr Dermatol 35:e52-e54
Kwak, Jeff W; Laskowski, Jennifer; Li, Howard Y et al. (2018) Complement Activation via a C3a Receptor Pathway Alters CD4+ T Lymphocytes and Mediates Lung Cancer Progression. Cancer Res 78:143-156
Hoefert, Jaimee E; Bjerke, Glen A; Wang, Dongmei et al. (2018) The microRNA-200 family coordinately regulates cell adhesion and proliferation in hair morphogenesis. J Cell Biol 217:2185-2204
Riemondy, Kent A; Gillen, Austin E; White, Emily A et al. (2018) Dynamic temperature-sensitive A-to-I RNA editing in the brain of a heterothermic mammal during hibernation. RNA 24:1481-1495
Sclafani, Robert A; Hesselberth, Jay R (2018) O Cdc7 kinase where art thou? Curr Genet 64:677-680
Shearn, Colin T; Orlicky, David J; Petersen, Dennis R (2018) Dysregulation of antioxidant responses in patients diagnosed with concomitant Primary Sclerosing Cholangitis/Inflammatory Bowel Disease. Exp Mol Pathol 104:1-8
Kim, Jihye; Yoo, Minjae; Shin, Jimin et al. (2018) Systems Pharmacology-Based Approach of Connecting Disease Genes in Genome-Wide Association Studies with Traditional Chinese Medicine. Int J Genomics 2018:7697356
Coleman, Carrie B; Lang, Julie; Sweet, Lydia A et al. (2018) Epstein-Barr Virus Type 2 Infects T Cells and Induces B Cell Lymphomagenesis in Humanized Mice. J Virol 92:
Petersen, Dennis R; Orlicky, David J; Roede, James R et al. (2018) Aberrant expression of redox regulatory proteins in patients with concomitant primary Sclerosing cholangitis/inflammatory bowel disease. Exp Mol Pathol 105:32-36

Showing the most recent 10 out of 1634 publications