The CCTO provides the infrastructure to support successful cancer clinical research across all departments within the University and supports cancer clinical trials at the U Chicago. It provides oversight and quality control through the implementation of policies and procedures, by centralizing regulatory and reporting functions, supervision of staff, auditing, and tracking of these activities with a centralized database. We are one of only four institutions nationally to be the lead institution for both an NCI Phase 1 cooperative agreement and a Phase 11 Clinical Trials Contract, are members of multiple cooperative groups, and have well established networks of affiliate institutions for both the Phase 11 program and CALGB/Alliance. On average, we have 300-350 therapeutic trials open to accrual per year, and an additional 100-150 open nontherapeutic trials. The office interacts with the Biostatistics Core Facility, the Protocol Review and Monitoring System (PRMS), and the UCCCC Informatics Group. Services provided by the CCTO can be broadly categorized under the following key functions: 1. Regulatory Affairs: Centralized regulatory management (e.g.. Clinical Trials Review Committee (CTRC) /IRB submission;INDs) for all UChicago cancer clinical trials regardless of sponsor, department, study type, or phase. Pediatric Oncology trials operate using a Satellite office, and follow all CCTO policies and procedures. 2. Protocol Tracking and Management: Centralized location and database (Velos eResearch) for tracking protocol-specific data and patient registration;provides web-based direct access (e.g., in clinics) to current protocol documents (e.g., consent forms);and report generation. 3. Affiliate Institution Coordination and Oversight: Infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCCC, including 7 CALGB/Alliance affiliate institutions,10 Phase 11 NCI contract affiliate institutions, and over 40 additional ad hoc affiliates participating in selected studies within the Disease Programs. 4. Quality Control: Training in clinical research and Velos eResearch;oversight of data and safety monitoring activities;coordination of the audit program;and development and implementation of Standard Operating Procedures (SOPs).
A critical component of the UCCCC's mission is to offer our patients the best and most personalized treatments available. This requires providing access to national cooperative group trials, NCI/CTEP sponsored trials as well as the development of new therapeutic approaches through translational research and the development of investigator-initiated trials. The CCTO is the backbone of these operations and provides services essential to the UCCCC clinical research operation.
|Sharifi, Marina N; Mowers, Erin E; Drake, Lauren E et al. (2016) Autophagy Promotes Focal Adhesion Disassembly and Cell Motility of Metastatic Tumor Cells through the Direct Interaction of Paxillin with LC3. Cell Rep 15:1660-72|
|Drazer, Michael W; Stadler, Walter M (2016) The Role of Testosterone in the Treatment of Castration-Resistant Prostate Cancer. Cancer J 22:330-333|
|Epel, Boris; Redler, Gage; Pelizzari, Charles et al. (2016) Approaching Oxygen-Guided Intensity-Modulated Radiation Therapy. Adv Exp Med Biol 876:185-93|
|Sweis, Randy F; Medved, Milica; Towey, Shannon et al. (2016) Dynamic Contrast-Enhanced Magnetic Resonance Imaging as a Pharmacodynamic Biomarker for Pazopanib in Metastatic Renal Carcinoma. Clin Genitourin Cancer :|
|Volden, Paul A; Skor, Maxwell N; Johnson, Marianna B et al. (2016) Mammary Adipose Tissue-Derived Lysophospholipids Promote Estrogen Receptor-Negative Mammary Epithelial Cell Proliferation. Cancer Prev Res (Phila) 9:367-78|
|Stein, Michelle M; Hrusch, Cara L; Gozdz, Justyna et al. (2016) Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. N Engl J Med 375:411-21|
|Baron, Beverly W; Baron, Rebecca M; Baron, Joseph M (2016) The Relationship between RUVBL1 (Pontin, TIP49, NMP238) and BCL6 in Benign and Malignant Human Lymphoid Tissues. Biochem Biophys Rep 6:1-8|
|King, Andrea C; Hasin, Deborah; O'Connor, Sean J et al. (2016) A Prospective 5-Year Re-examination of Alcohol Response in Heavy Drinkers Progressing in Alcohol Use Disorder. Biol Psychiatry 79:489-98|
|Appelbe, Oliver K; Zhang, Qingbei; Pelizzari, Charles A et al. (2016) Image-Guided Radiotherapy Targets Macromolecules through Altering the Tumor Microenvironment. Mol Pharm 13:3457-3467|
|Morrison, Gladys; Lenkala, Divya; LaCroix, Bonnie et al. (2016) Utility of patient-derived lymphoblastoid cell lines as an ex vivo capecitabine sensitivity prediction model for breast cancer patients. Oncotarget 7:38359-38366|
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