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).

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA014599-38
Application #
8486649
Study Section
Subcommittee G - Education (NCI)
Project Start
2013-04-01
Project End
2018-03-31
Budget Start
2013-04-23
Budget End
2014-03-31
Support Year
38
Fiscal Year
2013
Total Cost
$223,085
Indirect Cost
Name
University of Chicago
Department
Type
DUNS #
005421136
City
Chicago
State
IL
Country
United States
Zip Code
60637
Feng, Christine H; Gerry, Emily; Chmura, Steven J et al. (2015) An image-guided study of setup reproducibility of postmastectomy breast cancer patients treated with inverse-planned intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys 91:58-64
Ming, Mei; Zhao, Baozhong; Shea, Christopher R et al. (2015) Loss of sirtuin 1 (SIRT1) disrupts skin barrier integrity and sensitizes mice to epicutaneous allergen challenge. J Allergy Clin Immunol 135:936-45.e4
Ming, Mei; Zhao, Baozhong; Qiang, Lei et al. (2015) Effect of immunosuppressants tacrolimus and mycophenolate mofetil on the keratinocyte UVB response. Photochem Photobiol 91:242-7
Shah, Palak; He, Yu-Ying (2015) Molecular regulation of UV-induced DNA repair. Photochem Photobiol 91:254-64
Ming, Mei; Han, Weinong; Zhao, Baozhong et al. (2014) SIRT6 promotes COX-2 expression and acts as an oncogene in skin cancer. Cancer Res 74:5925-33
Ramírez, Jacqueline; Kim, Tae Won; Liu, Wanqing et al. (2014) A pharmacogenetic study of aldehyde oxidase I in patients treated with XK469. Pharmacogenet Genomics 24:129-32
Rudra, Sonali; Al-Hallaq, Hania A; Feng, Christine et al. (2014) Effect of RTOG breast/chest wall guidelines on dose-volume histogram parameters. J Appl Clin Med Phys 15:4547
Weng, Liming; Ziliak, Dana; Lacroix, Bonnie et al. (2014) Integrative "omic" analysis for tamoxifen sensitivity through cell based models. PLoS One 9:e93420
Stumpf, Melanie; Zhou, Xuyu; Chikuma, Shunsuke et al. (2014) Tyrosine 201 of the cytoplasmic tail of CTLA-4 critically affects T regulatory cell suppressive function. Eur J Immunol 44:1737-46
Geeleher, Paul; Cox, Nancy J; Huang, R Stephanie (2014) Clinical drug response can be predicted using baseline gene expression levels and in vitro drug sensitivity in cell lines. Genome Biol 15:R47

Showing the most recent 10 out of 354 publications