Abstract

CLINICAL TRIALS OFFICE The Clinical Trials Office (CTO) provides infrastructure support for the conduct of clinical trials at the University of Michigan Comprehensive Cancer Center. CTO services are grouped into three major categories;regulatory services, data management services, and information technologies services. Major areas of responsibility include support for regulatory submissions to the IRB, two Protocol Review Committees (therapeutic and prevention), GCRC and other institutional review committees, FDA, and NCI. The CTO provides data management services for PRC-approved clinical trials as well as serving as a centralized data repository for research data generated on clinical trials. These services include study implementation, data collection and entry, and submission to investigators and outside sponsors. The information technology services include Case Report Form (CRF) development and database implementation and maintenance. The primary mission of the CTO is to assist the Cancer Center investigators in the development, conduct, and reporting of innovative clinical research in an efficient, regulatory compliant, and scientifically sound manner.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA046592-22
Application #
7917282
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2009-06-01
Budget End
2010-05-31
Support Year
22
Fiscal Year
2009
Total Cost
$319,644
Indirect Cost

  Institution

Name
University of Michigan Ann Arbor
Department
Type
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109

  Publications

Schofield, Heather K; Zeller, Jörg; Espinoza, Carlos et al. (2018) Mutant p53R270H drives altered metabolism and increased invasion in pancreatic ductal adenocarcinoma. JCI Insight 3:
Liu, Gang; Mukherjee, Bhramar; Lee, Seunggeun et al. (2018) Robust Tests for Additive Gene-Environment Interaction in Case-Control Studies Using Gene-Environment Independence. Am J Epidemiol 187:366-377
Gleber-Netto, Frederico O; Zhao, Mei; Trivedi, Sanchit et al. (2018) Distinct pattern of TP53 mutations in human immunodeficiency virus-related head and neck squamous cell carcinoma. Cancer 124:84-94
Stoffel, Elena M; Koeppe, Erika; Everett, Jessica et al. (2018) Germline Genetic Features of Young Individuals With Colorectal Cancer. Gastroenterology 154:897-905.e1
Djuric, Zora; Bassis, Christine M; Plegue, Melissa A et al. (2018) Colonic Mucosal Bacteria Are Associated with Inter-Individual Variability in Serum Carotenoid Concentrations. J Acad Nutr Diet 118:606-616.e3
Mann, Jacqueline E; Smith, Joshua D; Birkeland, Andrew C et al. (2018) Analysis of tumor-infiltrating CD103 resident memory T-cell content in recurrent laryngeal squamous cell carcinoma. Cancer Immunol Immunother :
Jiagge, Evelyn; Jibril, Aisha Souleiman; Davis, Melissa et al. (2018) Androgen Receptor and ALDH1 Expression Among Internationally Diverse Patient Populations. J Glob Oncol :1-8
Bowers, Emily; Slaughter, Anastasiya; Frenette, Paul S et al. (2018) Granulocyte-derived TNF? promotes vascular and hematopoietic regeneration in the bone marrow. Nat Med 24:95-102
Holt, Melissa C; Assar, Zahra; Beheshti Zavareh, Reza et al. (2018) Biochemical Characterization and Structure-Based Mutational Analysis Provide Insight into the Binding and Mechanism of Action of Novel Aspartate Aminotransferase Inhibitors. Biochemistry 57:6604-6614
Wang, Yin; Day, Mark L; Simeone, Diane M et al. (2018) 3-D Cell Culture System for Studying Invasion and Evaluating Therapeutics in Bladder Cancer. J Vis Exp :

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