Since its inception in 1990, the Clinical &Translational Research Center (CTRC) has served as the primary site for patient-oriented, protocol-based, innovative clinical and translational research. Key phase I and II studies have contributed to the development of 18 new FDA-approved cancer drugs since 2002. Highest priority is given to studies that seek to answer biologically-based research questions. NIH peer-reviewed studies have comprised >15% of CTRC activity and >37% of patient registrations since 2002. The total CTRC annual budget has increased to $3.5 million (20.5 clinical FTEs and 33.6 lab FTEs). The laboratory budget is $1.8M of this total, and only 14% ($254K) of the lab budget is requested in this proposal. The CTRC provides outstanding nursing care, full phlebotomy/lab services for pharmacokinetic (PK) and pharmacodynamic (PD) studies, as well as rigorous research infrastructure and oversight. Core grant funding is leveraged more than 2:1 to support correlative studies that could not be conducted otherwise. In the last 5 years, 7,750 patient registrations recorded on over 450 protocols, representing usage by 96 investigators from 16 programs. In 2007 alone, there have been 15,099 patient visits and >12,000 PK/PD timepoints. The CTRC uses a broad array of targeted small molecules, immunologic agents, signal transduction inhibitors, epigenetic modulators, vaccines, and proteosome inhibitors. Classic cytotoxic agents comprise less than 1/3 of all drug studies. The unit received a highly-favorable review in 2003 with the explicit recommendation to strengthen charge capture for billable services. Since that time, we have instituted a robust accounting and billing system that now contributes over $500,000 (28%) to the total budget. A medical director and nurse manager supervise daily activities and a 20-member oversight committee directs development and prioritization of studies. A recently-recruited PhD Laboratory Manager will provide oversight of our increasingly-complex phase I studies. New services include: a computerized cataloging system for frozen specimens;specialized preparation for proteomics, DMA, RNA analysis, and mononuclear cell fractionation;real-time Principal Investigator email notification of sample shipments;24-hr phlebotomy coverage;and a secure """"""""just-in-time"""""""" inventory system for protocol-specific PK and PD kits. Future plans include: re-organization of the Lab Service into 4 teams to improve communication with the individual Cancer Center programs, and expansion of lab space to accommodate 30% annual growth; development of a comprehensive web-based Oracle application to replace paper and handwritten systems. In February 2007, the CTRC attracted a $1.5M gift to develop a computerized Advanced Research Management and Data Analysis system (the ARMADA project), leveraging further the value of NIH's investment. Funds requested will support the critical phlebotomy and laboratory services needed to execute today's highly-complex translational cancer drug development.

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 Texas MD Anderson Cancer Center
United States
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Yedururi, Sireesha; Terpenning, Silanath; Gupta, Sanjay et al. (2017) Radiofrequency Ablation of Hepatic Tumor: Subjective Assessment of the Perilesional Vascular Network on Contrast-Enhanced Computed Tomography Before and After Ablation Can Reliably Predict the Risk of Local Recurrence. J Comput Assist Tomogr 41:607-613
Montalban-Bravo, G; Huang, X; Jabbour, E et al. (2017) A clinical trial for patients with acute myeloid leukemia or myelodysplastic syndromes not eligible for standard clinical trials. Leukemia 31:318-324
Tadros, Audree B; Smith, Benjamin D; Shen, Yu et al. (2017) Ductal Carcinoma In Situ and Margins <2?mm: Contemporary Outcomes With Breast Conservation. Ann Surg :
Ikoma, Naruhiko; Raghav, Kanwal; Chang, George (2017) An Update on Randomized Clinical Trials in Metastatic Colorectal Carcinoma. Surg Oncol Clin N Am 26:667-687
Alhuraiji, Ahmad; Jain, Nitin (2017) Immunofluorescence staining with an antipromyelocytic leukemia antibody for a rapid diagnosis of acute promyelocytic leukemia. Hematol Oncol Stem Cell Ther 10:33-34
Lin, Heather Y; Bedrosian, Isabelle; Babiera, Gildy V et al. (2017) Using the National Cancer Data Base for quality evaluation to assess adherence to treatment guidelines for nonmetastatic inflammatory breast cancer. Cancer 123:2618-2625
Rozovski, Uri; Harris, David M; Li, Ping et al. (2017) Constitutive Phosphorylation of STAT3 by the CK2-BLNK-CD5 Complex. Mol Cancer Res 15:610-618
Masarova, Lucia; Kantarjian, Hagop; Garcia-Mannero, Guillermo et al. (2017) Harnessing the Immune System Against Leukemia: Monoclonal Antibodies and Checkpoint Strategies for AML. Adv Exp Med Biol 995:73-95
Palacios, Cristina; Daniel, Carrie R; Tirado-Gómez, Maribel et al. (2017) Dietary Patterns in Puerto Rican and Mexican-American Breast Cancer Survivors: A Pilot Study. J Immigr Minor Health 19:341-348
Gunther, Jillian R; Chadha, Awalpreet S; Shin, Ui Sup et al. (2017) Preoperative radiation dose escalation for rectal cancer using a concomitant boost strategy improves tumor downstaging without increasing toxicity: A matched-pair analysis. Adv Radiat Oncol 2:455-464

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