The CPDMU is a shared AECC resource widely used by members from the various oncologic disciplines to perform clinical and translational trials. The CPDMU plays a central role that supports other components of the clinical trials infrastructure including the Protocol Review and Monitoring System (PRMS), Protocol Specific Research Support (PSRS), and Data and Safety Monitoring Committee (DSMC). The CPDMU administrative office is located on the second floor of the Weiler Division of Montefiore Medical Center (MMC), and is immediately adjacent to the administrative office of CPDMU Director and to the Chanin Cancer Research Institute. The CPDMU performs the following functions: protocol submission, regulatory affairs, data management and development, facilitates interactions with the Bioinformatics and Biostatistics Shared Resources, provides quality control, and serves as a resource for AECC investigators who require assistance in the design of clinical trials. Services provided include: cataloging, preparing, and submitting all new clinical protocols, informed consent documents, and HIPAA authorization documents to the PRMS and to the AECOM CCI and/or MMC IRB. Additional services include preparing a Spanish version of informed consent documents, conforming to CCI/IRB guidelines for a fully translated consent for non-English speaking subjects cataloging and submission of all amendments, collection, processing and distribution of all internal and external adverse events including distributions to IRB and governmental agencies, initiation of all new clinical protocols, submission of sequence numbers to pharmacy (insuring that all patients enrolled in clinical trials are properly entered into the clinical database), overseeing eligibility check, registration and enrollment of new patients, overseeing proper collection of data, recording of toxicities, dose modifications, performance of tests in a timely fashion, submission of forms in a timely fashion, and scheduling and performance of follow-ups. There are approximately 25 F.T.E. CPDMU staff funded by the CCSG. Clinical trials are supported by a N01 Phase II Contract (CA CM-17103), ECOG U10 grant (CA14959), AIDS Malignancy Consortium U01 core site subcontract, along with funding from investigator-initiated NCI and pharmaceutical industry studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA013330-39
Application #
8294861
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2013-06-30
Budget Start
2011-07-01
Budget End
2012-06-30
Support Year
39
Fiscal Year
2011
Total Cost
$452,667
Indirect Cost
Name
Albert Einstein College of Medicine
Department
Type
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
Stepankova, Martina; Bartonkova, Iveta; Jiskrova, Eva et al. (2018) Methylindoles and Methoxyindoles are Agonists and Antagonists of Human Aryl Hydrocarbon Receptor. Mol Pharmacol 93:631-644
Anayannis, Nicole V; Schlecht, Nicolas F; Ben-Dayan, Miriam et al. (2018) Association of an intact E2 gene with higher HPV viral load, higher viral oncogene expression, and improved clinical outcome in HPV16 positive head and neck squamous cell carcinoma. PLoS One 13:e0191581
Ingram, Jessica R; Blomberg, Olga S; Rashidian, Mohammad et al. (2018) Anti-CTLA-4 therapy requires an Fc domain for efficacy. Proc Natl Acad Sci U S A 115:3912-3917
Maggi, Elaine C; Gravina, Silvia; Cheng, Haiying et al. (2018) Development of a Method to Implement Whole-Genome Bisulfite Sequencing of cfDNA from Cancer Patients and a Mouse Tumor Model. Front Genet 9:6
Chen, Zigui; Schiffman, Mark; Herrero, Rolando et al. (2018) Classification and evolution of human papillomavirus genome variants: Alpha-5 (HPV26, 51, 69, 82), Alpha-6 (HPV30, 53, 56, 66), Alpha-11 (HPV34, 73), Alpha-13 (HPV54) and Alpha-3 (HPV61). Virology 516:86-101
Dulyaninova, Natalya G; Ruiz, Penelope D; Gamble, Matthew J et al. (2018) S100A4 regulates macrophage invasion by distinct myosin-dependent and myosin-independent mechanisms. Mol Biol Cell 29:632-642
Heo, Moonseong; Kim, Namhee; Rinke, Michael L et al. (2018) Sample size determinations for stepped-wedge clinical trials from a three-level data hierarchy perspective. Stat Methods Med Res 27:480-489
Kunnath-Velayudhan, Shajo; Porcelli, Steven A (2018) Isolation of intact RNA from murine CD4+ T cells after intracellular cytokine staining and fluorescence-activated cell sorting. J Immunol Methods 456:77-80
Zamurrad, Sumaira; Hatch, Hayden A M; Drelon, Coralie et al. (2018) A Drosophila Model of Intellectual Disability Caused by Mutations in the Histone Demethylase KDM5. Cell Rep 22:2359-2369
Sparano, Joseph A (2018) Prognostic gene expression assays in breast cancer: are two better than one? NPJ Breast Cancer 4:11

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