? Clinical Protocol and Data Management Clinical and Protocol Data Management: Provides centralized oversight and support for coordinating, facilitating and reporting on cancer clinical trials managed by the CFCCC's Stern Center for Cancer Clinical Trials & Research, which comprises the Regulatory Affairs Office (RAO) and Clinical Research Office (CRO). RAO and CRO services are provided for the lifecycle of a research study, which includes development and implementation support, as well as quality control functions. CRO coordinates study management activities including screening subjects and collecting and recording study data. RAO manages the committee coordination of the Protocol Review and Monitoring Committee (PRMC) and Data and Safety Monitoring Board (DSMB) and the submission of regulatory documents to all committees. Committee coordination is responsible for managing all Disease Oriented Team (DOT), PRMC, and DSMB meetings. The regulatory coordinators submit all regulatory committee applications. RAO and CRO also work closely with the Clinical Informatics Department of the UC Irvine Medical Center to manage the clinical trials management system, OnCore, which houses protocol data necessary for planning, reporting and internal oversight. Data and Safety Monitoring: Provides oversight and monitoring for the conduct of clinical trials to ensure the safety of participants and the validity and integrity of data for all UC Irvine investigator-initiated trials (IITs). The Data and Safety Monitoring Board (DSMB) is responsible for reviewing data and safety monitoring plans and assigns risk levels to UC Irvine IITs, following its NCI-approved Data and Safety Monitoring Plan. The frequency of review of trials is commensurate with the level of risk for IITs. The DSMB reviews patient safety data, efficacy related to protocol stopping rules, possible futility of protocols, data quality for all IIT protocols, monthly assessment of adverse events and serious adverse events, and protocol interim analyses. Inclusion of Women and Minorities: The CFCCC is the only NCI-designated comprehensive cancer center in Orange County (OC) and the majority of the participant base derives directly from OC residents for the accrual of women and minorities. The new Pacific Breast Care Center continues to increase clinical trial implementation and recruitment efforts focusing on women. Additionally, the Gynecological DOT focuses on the protocol portfolio and works to identify new protocols to open in breast, cervical, and ovarian cancers. Inclusion of Children: Pediatric oncology patient care and research of UC Irvine is carried out at the Hyundai Cancer Institute at Children's Hospital of Orange County (CHOC Children's). A formal UC Irvine/CHOC Affiliation Agreement was approved by the University of California Regents in 2009, and CHOC Children's is being included as a formal affiliate of the CFCCC in this competing renewal application.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA062203-19
Application #
8999879
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
1997-09-11
Project End
2021-01-31
Budget Start
2016-02-01
Budget End
2017-01-31
Support Year
19
Fiscal Year
2016
Total Cost
Indirect Cost
Name
University of California Irvine
Department
Type
DUNS #
046705849
City
Irvine
State
CA
Country
United States
Zip Code
92617
Konstorum, Anna; Lowengrub, John S (2018) Activation of the HGF/c-Met axis in the tumor microenvironment: A multispecies model. J Theor Biol 439:86-99
Yan, Huaming; Konstorum, Anna; Lowengrub, John S (2018) Three-Dimensional Spatiotemporal Modeling of Colon Cancer Organoids Reveals that Multimodal Control of Stem Cell Self-Renewal is a Critical Determinant of Size and Shape in Early Stages of Tumor Growth. Bull Math Biol 80:1404-1433
Wang, Xiaolin; Zhao, Da; Phan, Duc T T et al. (2018) A hydrostatic pressure-driven passive micropump enhanced with siphon-based autofill function. Lab Chip 18:2167-2177
Flather, Dylan; Nguyen, Joseph H C; Semler, Bert L et al. (2018) Exploitation of nuclear functions by human rhinovirus, a cytoplasmic RNA virus. PLoS Pathog 14:e1007277
Hou, Jue; Williams, Joshua; Botvinick, Elliot L et al. (2018) Visualization of Breast Cancer Metabolism Using Multimodal Nonlinear Optical Microscopy of Cellular Lipids and Redox State. Cancer Res 78:2503-2512
George, Andrée S; Cox, Clayton E; Desai, Prerak et al. (2018) Interactions of Salmonella enterica Serovar Typhimurium and Pectobacterium carotovorum within a Tomato Soft Rot. Appl Environ Microbiol 84:
Reidling, Jack C; Relaño-Ginés, Aroa; Holley, Sandra M et al. (2018) Human Neural Stem Cell Transplantation Rescues Functional Deficits in R6/2 and Q140 Huntington's Disease Mice. Stem Cell Reports 10:58-72
Lagarrigue, Frederic; Gingras, Alexandre R; Paul, David S et al. (2018) Rap1 binding to the talin 1 F0 domain makes a minimal contribution to murine platelet GPIIb-IIIa activation. Blood Adv 2:2358-2368
Santos, Rommel A; Fuertes, Ariel J C; Short, Ginger et al. (2018) DSCAM differentially modulates pre- and postsynaptic structural and functional central connectivity during visual system wiring. Neural Dev 13:22
Ullmer, Wendy; Semler, Bert L (2018) Direct and Indirect Effects on Viral Translation and RNA Replication Are Required for AUF1 Restriction of Enterovirus Infections in Human Cells. MBio 9:

Showing the most recent 10 out of 1106 publications