Core C : Clinical Trials The primary objective of the clinical trials core is to provide assistance to the projects in all aspects of clinical trial design, implementation, regulation, data collection, and interpretation, pharmacokinetics, and other specimen collections for targeted therapy investigations and/or banking. Specifically, the clinical trials core facilitates protocol writing and preparation, submission, and regulatory review, interacting directly with the NCI, FDA, Industry sponsors and IRB as needed. The clinical trials core maintains the database and all aspects of data management for patients enrolled on clinical trials within the SPORE. Adverse event reporting and data and safety monitoring for all protocols on the SPORE application are coordinated through the clinical trials core. The clinical trials core seamlessly interacts with the specimen core, providing clinical, epidemiologic and demographic data on patients consenting to tissue banking, and with the biostatistics core, providing timely reports and data for analysis.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Specialized Center (P50)
Project #
5P50CA130805-05
Application #
8381198
Study Section
Special Emphasis Panel (ZCA1-GRB-I)
Project Start
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
5
Fiscal Year
2012
Total Cost
$390,826
Indirect Cost
$47,346
Name
University of Rochester
Department
Type
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
Holkova, Beata; Zingone, Adriana; Kmieciak, Maciej et al. (2016) A Phase II Trial of AZD6244 (Selumetinib, ARRY-142886), an Oral MEK1/2 Inhibitor, in Relapsed/Refractory Multiple Myeloma. Clin Cancer Res 22:1067-75
Akhenblit, Paul J; Hanke, Neale T; Gill, Alexander et al. (2016) Assessing Metabolic Changes in Response to mTOR Inhibition in a Mantle Cell Lymphoma Xenograft Model Using AcidoCEST MRI. Mol Imaging 15:
Holkova, Beata; Kmieciak, Maciej; Bose, Prithviraj et al. (2016) Phase 1 trial of carfilzomib (PR-171) in combination with vorinostat (SAHA) in patients with relapsed or refractory B-cell lymphomas. Leuk Lymphoma 57:635-43
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Kelly, Jennifer L; Salles, Gilles; Goldman, Bryan et al. (2015) Low Serum Vitamin D Levels Are Associated With Inferior Survival in Follicular Lymphoma: A Prospective Evaluation in SWOG and LYSA Studies. J Clin Oncol 33:1482-90
Chen, Shuang; Zhang, Yu; Zhou, Liang et al. (2014) A Bim-targeting strategy overcomes adaptive bortezomib resistance in myeloma through a novel link between autophagy and apoptosis. Blood 124:2687-97
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