The Clinical Research Shared Service (CRSS) participates with members of clinical teams and investigators on all details of clinical trial design, review, implementation, and preparation for quality assurance monitoring, including interactions with the Institutional Review Board of the University of Maryland School of Medicine, the Clinical Research Committee (CRC) (or Protocol Review and Monitoring System) of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC), and the Data Safety Monitoring/Quality Assurance Committee of UMGCC. In addition, CRSS participates in negotiating with sponsors to develop budgets for clinical trials in conjunction with the Office of Research and Development at the University of Maryland-Baltimore (UMB). CRSS utilizes and manages the Oncore? database for all patients?completing case report forms for industry-sponsored studies and entering data into appropriate databases for Phase I or Phase 11 trials sponsored by the National Cancer Institute and cooperative group sponsored trials. Oncore? is also utilized for customized case report forms in investigator-initiated protocols. CRSS also collects information and forwards records of underserved minority accrual to clinical trials to Dr. Shana Ntiri, medical director of the Baltimore City Cancer Program, to facilitate periodic reviews in conjunction with CRC. Dr. Ntiri serves as the liaison for clinical research community outreach. During fiscal year 2010 CRSS costs were $3,325,306, of which $280,124 were from the Cancer Center Support Grant and $358,876 were from other peer-reviewed grant support. During the latest 3-year grant period, 37 publications were supported by CRSS, serving the Hormone Responsive Cancers and Experimental Therapeutics Programs at UMGCC.

Public Health Relevance

CRSS is highly relevant to the research mission of UMGCC, because it is the vehicle by which UMGCC delivers possibly life-saving, in some cases, and life-enhancing, in all cases, clinical protocols that represent the current best research questions across the spectrum of clinical cancer research. CRSS provides a uniform order of procedure for clinical research process available to all UMGCC investigators. It actively promotes the inclusion of underserved minorities in the research enterprise of UMGCC.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee G - Education (NCI)
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University of Maryland Baltimore
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Appelt, Ane L; Vogelius, Ivan R; Pløen, John et al. (2014) Long-term results of a randomized trial in locally advanced rectal cancer: no benefit from adding a brachytherapy boost. Int J Radiat Oncol Biol Phys 90:110-8
Vogelius, Ivan R; Bentzen, Søren M (2014) Hypofractionated radiation therapy for prostate cancer: more food for thought from recent trial. J Clin Oncol 32:1852-3
Bao, Ting; Cai, Ling; Snyder, Claire et al. (2014) Patient-reported outcomes in women with breast cancer enrolled in a dual-center, double-blind, randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor-induced musculoskeletal symptoms. Cancer 120:381-9
Barnett, Gillian C; Thompson, Deborah; Fachal, Laura et al. (2014) A genome wide association study (GWAS) providing evidence of an association between common genetic variants and late radiotherapy toxicity. Radiother Oncol 111:178-85
Bentzen, S M; Yarnold, J (2014) A toast to the silver anniversary of Clinical Oncology: a quarter of a century of advances in evidence-based radiation dose fractionation. Clin Oncol (R Coll Radiol) 26:599-601
Håkansson, Katrin; Specht, Lena; Aznar, Marianne C et al. (2014) Prescribing and evaluating target dose in dose-painting treatment plans. Acta Oncol 53:1251-6
Due, Anne K; Vogelius, Ivan R; Aznar, Marianne C et al. (2014) Recurrences after intensity modulated radiotherapy for head and neck squamous cell carcinoma more likely to originate from regions with high baseline [18F]-FDG uptake. Radiother Oncol 111:360-5
Song, Xiaomeng; Xia, Ronghui; Li, Jiang et al. (2014) Common and complex Notch1 mutations in Chinese oral squamous cell carcinoma. Clin Cancer Res 20:701-10
Gojo, Ivana; Tan, Ming; Fang, Hong-Bin et al. (2013) Translational phase I trial of vorinostat (suberoylanilide hydroxamic acid) combined with cytarabine and etoposide in patients with relapsed, refractory, or high-risk acute myeloid leukemia. Clin Cancer Res 19:1838-51
Natarajan, Karthika; Xie, Yingqiu; Burcu, Mehmet et al. (2013) Pim-1 kinase phosphorylates and stabilizes 130 kDa FLT3 and promotes aberrant STAT5 signaling in acute myeloid leukemia with FLT3 internal tandem duplication. PLoS One 8:e74653

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