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)
Project #
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Study Section
Subcommittee G - Education (NCI)
Project Start
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University of Texas MD Anderson Cancer Center
United States
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Van Roosbroeck, Katrien; Fanini, Francesca; Setoyama, Tetsuro et al. (2016) Combining anti-miR-155 with chemotherapy for the treatment of lung cancers. Clin Cancer Res :
Cassani, Lisa S; Raju, Gottumukkala S (2016) Techniques for management of bleeding associated with colonic endoscopic mucosal resection. Gastrointest Endosc 83:469-70
Zargar, Homayoun; Atwell, Thomas D; Cadeddu, Jeffrey A et al. (2016) Cryoablation for Small Renal Masses: Selection Criteria, Complications, and Functional and Oncologic Results. Eur Urol 69:116-28
Ma, Junsheng; Hobbs, Brian P; Stingo, Francesco C (2016) Integrating genomic signatures for treatment selection with Bayesian predictive failure time models. Stat Methods Med Res :
Jinesh, Goodwin G; Kamat, Ashish M (2016) Endocytosis and serpentine filopodia drive blebbishield-mediated resurrection of apoptotic cancer stem cells. Cell Death Discov 2:
Maiti, Abhishek; Cortes, Jorge E; Brown, Yolanda D et al. (2016) Phase I/II study of low-dose azacytidine in patients with chronic myeloid leukemia who have minimal residual disease while receiving therapy with tyrosine kinase inhibitors. Leuk Lymphoma :1-4
Visone, R; Pallante, P; Vecchione, A et al. (2016) Specific microRNAs are downregulated in human thyroid anaplastic carcinomas. Oncogene 35:5214
Zhou, Fuling; Li, Ming; Wei, Yongchang et al. (2016) Activation of HERV-K Env protein is essential for tumorigenesis and metastasis of breast cancer cells. Oncotarget :
Gamaletsou, Maria N; Rammaert, Blandine; Bueno, Marimelle A et al. (2016) Candida Arthritis: Analysis of 112 Pediatric and Adult Cases. Open Forum Infect Dis 3:ofv207
Parra, Edwin R; Behrens, Carmen; Rodriguez-Canales, Jaime et al. (2016) Image Analysis-based Assessment of PD-L1 and Tumor-Associated Immune Cells Density Supports Distinct Intratumoral Microenvironment Groups in Non-small Cell Lung Carcinoma Patients. Clin Cancer Res :

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