Clinical Trials Office and Data and Safety Monitoring (DSM) Description The Masonic Cancer Center (MCC) Clinical Trials Office (CTO) was formally established in 2001 with the goal of enhancing MCC members'ability to conduct clinical cancer research by providing centralized and specialized resources and expertise. It assists MCC investigators in developing, activating, and completing scientifically meritorious clinical trials in a high-quality, efficient, cost-effective, centralized manner. At the same time, it ensures the validity and integrity of data in order to fulfill all NCI, federal, and local regulatory requirements. In fiscal year 2012, the CTO opened 42 clinical trials to accrual. As of July 2012, 296 active clinical trials were using CTO services, of which 134 were investigator initiated, 82 were National Cooperative Group trials, and 80 were industry trials. The CTO is currently managing 27 Investigational New Drug Application (IND)/lnvestigational Device Exemption (IDE) trials. A total of 1220 patients (active treatment and follow-up) are currently being followed by the CTO. The CTO focuses on investigator-initiated trials and the translation of basic scientific findings to clinical trials, effectively leveraging MCC resources for the management of our therapeutic translational pipeline. The CTO provides the following major areas of support to MCC investigators: clinical services and data management, regulatory affairs, and Clinical Trials Reporting Program registrations and updates, protocol development, clinical trial finance management, project management, system management, clinical trial monitoring and auditing. The MCC Data and Safety Monitoring Plan (DSMP) details the roles and responsibilities of 3 accountable units (PI, MCC, and the University of Minnesota) and the processes that are used by these accountable units to ensure that the highest-quality clinical research is conducted while participant safety is optimized. The current DSMP was approved by the NCI on February 16, 2012. The PI is responsible for all aspects of trial conduct, including clinical trial management, data acquisition, and data and safety monitoring. The MCC has the responsibility of clinical research oversight. The University has oversight for conflict of interest and regulatory standards.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Minnesota Twin Cities
United States
Zip Code
Abbott, Kenneth L; Nyre, Erik T; Abrahante, Juan et al. (2015) The Candidate Cancer Gene Database: a database of cancer driver genes from forward genetic screens in mice. Nucleic Acids Res 43:D844-8
Yee, Douglas (2015) A tale of two receptors: insulin and insulin-like growth factor signaling in cancer. Clin Cancer Res 21:667-9
Daniel, A R; Gaviglio, A L; Knutson, T P et al. (2015) Progesterone receptor-B enhances estrogen responsiveness of breast cancer cells via scaffolding PELP1- and estrogen receptor-containing transcription complexes. Oncogene 34:506-15
Upadhyaya, Pramod; Hecht, Stephen S (2015) Quantitative analysis of 3'-hydroxynorcotinine in human urine. Nicotine Tob Res 17:524-9
Patel, Yesha M; Stram, Daniel O; Wilkens, Lynne R et al. (2015) The contribution of common genetic variation to nicotine and cotinine glucuronidation in multiple ethnic/racial populations. Cancer Epidemiol Biomarkers Prev 24:119-27
Chen, Liddy M; Ibrahim, Joseph G; Chu, Haitao (2014) Flexible stopping boundaries when changing primary endpoints after unblinded interim analyses. J Biopharm Stat 24:817-33
Takahashi, Yutaka; Hui, Susanta K (2014) Fast, simple, and informative patient-specific dose verification method for intensity modulated total marrow irradiation with helical tomotherapy. Radiat Oncol 9:34
Cooley, Sarah; Weisdorf, Daniel J; Guethlein, Lisbeth A et al. (2014) Donor killer cell Ig-like receptor B haplotypes, recipient HLA-C1, and HLA-C mismatch enhance the clinical benefit of unrelated transplantation for acute myelogenous leukemia. J Immunol 192:4592-600
Gorden, Brandi H; Kim, Jong-Hyuk; Sarver, Aaron L et al. (2014) Identification of three molecular and functional subtypes in canine hemangiosarcoma through gene expression profiling and progenitor cell characterization. Am J Pathol 184:985-95
Landman, Sean R; Hwang, Tae Hyun; Silverstein, Kevin A T et al. (2014) SHEAR: sample heterogeneity estimation and assembly by reference. BMC Genomics 15:84

Showing the most recent 10 out of 319 publications