The goal of the Protocol Specific Research (PSR) Program is to provide data management and other infrastructure support for novel clinical trials designed and implemented by UCCC memebrs. These clinical trials are innovative, feasibility (i.e., pre phase 1, pilot) and phase I clinical interventions focused on testing an agent or device for the diagnosis, prevention, detection or treatment of cancer. Positive trials have led to larger externally funded studies, either through cooperative group mechanisms or through independent grant support. The UCCC has a formal mechanism for prioritizing trials for funding with PSR support. This process is overseen by the PSR Medical Director and the Chair of the PRMC. Peer-review for unfunded investigator initiated studies is carried out monthly after a center-wide RFA notification. Reviewers are assigned by Dr. Kane to review a study eligible for PSR funding. This process occurs in conjunction with the PRMC's review in order to avoid duplication of efforts. Eligibility and prioritization is determined based on defined criteria Some Pis are encouraged to revise and resubmit the study based on the anonymous written reviews. Funds are distributed based on calculation of the time and effort needed for Clinical Research Coordinator (CRC) and data management responsibilities and can be used for CRC and data management support only. Investigators are required to seek support through other mechanisms for patient care and/or other expenses, if needed. 37 PSR approved trials have been active during the current funding period. To date, total accrual for these trials has been 734. This is a remarkable increase from the past two funding CCSG periods at 281 (2000) and 401 (2005). Based on our proposed budget for 2.67 FTEs for CRC support, our average annual accrual of 122 averages to -46 accruals per CRC per year, a significant workload since these early phase trials often require frequent patient visits, pharmacokinetics and specimen collection in addition to data entry. The outcomes thus far have resulted in 22 published manuscripts, 3 abstracts and presentations of data at national or international meetings, 4 on-going research projects with funding from external sponsors including the Susan G. Komen Foundation and SWOG;and two others under development (RTOG) and submitted (R21). Despite accrual growth, we wish to further expand the program's success and impact in the field in the next funding period by fundraising to create an endowment that would provide funds and services for investigators to use in preparation of subsequent larger studies after successful completion of PSR trials. This will include protocol development, fiscal and biostatistical support and design services.

Public Health Relevance

The Protocol Specific Research component of a Cancer Center Support Grant provides specific support for short-term, feasibility (i.e. pre-phase 1 and pilot) and phase I clinical trials that originate with the investigators at the University of Colorado Cancer Center. This support allow investigators to test novel ideas and generate preliminary data that can be used as the basis for later phase trials funded through competitive grant applications, cooperative groups or industry.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA046934-26
Application #
8616650
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-02-01
Budget End
2015-01-31
Support Year
26
Fiscal Year
2014
Total Cost
$149,171
Indirect Cost
$51,778
Name
University of Colorado Denver
Department
Type
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
New, Melissa L; White, Collin M; McGonigle, Polly et al. (2018) Prostacyclin and EMT Pathway Markers for Monitoring Response to Lung Cancer Chemoprevention. Cancer Prev Res (Phila) 11:643-654
Vartuli, Rebecca L; Zhou, Hengbo; Zhang, Lingdi et al. (2018) Eya3 promotes breast tumor-associated immune suppression via threonine phosphatase-mediated PD-L1 upregulation. J Clin Invest 128:2535-2550
Scott, Aaron J; Arcaroli, John J; Bagby, Stacey M et al. (2018) Cabozantinib Exhibits Potent Antitumor Activity in Colorectal Cancer Patient-Derived Tumor Xenograft Models via Autophagy and Signaling Mechanisms. Mol Cancer Ther 17:2112-2122
da Silva, Raquel Frenedoso; Dhar, Deepanshi; Raina, Komal et al. (2018) Nintedanib inhibits growth of human prostate carcinoma cells by modulating both cell cycle and angiogenesis regulators. Sci Rep 8:9540
Majtan, Tomas; Jones Jr, Wendell; Krijt, Jakub et al. (2018) Enzyme Replacement Therapy Ameliorates Multiple Symptoms of Murine Homocystinuria. Mol Ther 26:834-844
Dhar, Deepanshi; Deep, Gagan; Kumar, Sushil et al. (2018) Bitter melon juice exerts its efficacy against pancreatic cancer via targeting both bulk and cancer stem cells. Mol Carcinog 57:1166-1180
Donson, Andrew M; Amani, Vladimir; Warner, Elliot A et al. (2018) Identification of FDA-Approved Oncology Drugs with Selective Potency in High-Risk Childhood Ependymoma. Mol Cancer Ther 17:1984-1994
Branchford, B R; Stalker, T J; Law, L et al. (2018) The small-molecule MERTK inhibitor UNC2025 decreases platelet activation and prevents thrombosis. J Thromb Haemost 16:352-363
Pei, Shanshan; Minhajuddin, Mohammad; Adane, Biniam et al. (2018) AMPK/FIS1-Mediated Mitophagy Is Required for Self-Renewal of Human AML Stem Cells. Cell Stem Cell 23:86-100.e6
Ren, Shengxiang; Rivard, Christopher J; Yu, Hui et al. (2018) A miRNA Panel Predicts Sensitivity of FGFR Inhibitor in Lung Cancer Cell Lines. Clin Lung Cancer 19:450-456

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