The goal of the Clinical Trials Core (CTC) is to provide support for clinical trials designed and implemented for SPORE projects. The support includes assistance with trial preparation, regulatory issues, data safety and monitoring, auditing, conduct, and reporting. Our increasing understanding of the molecular basis of lung cancer has reinforced the need to continue conducting studies which involve the collection of both clinical data and specimens for molecular analyses. This translational approach allows for the investigation of biological pathways of lung carcinogenesis in human tissue, and acts as a powerful tool in the evaluation of novel strategies for the prevention, screening, early detection, and treatment of lung cancer. The CTC has been essential in translating the science generated from each of the individual projects. The CTC has played a crucial role in the Colorado SPORE due the nature of our trials. Our trials have largely focused on chemoprevention, early detection, and tissue acquisition, and have robust enrollments and specimens. Trial subjects are predominantly enrolled from pulmonary clinics at affiliated Hospitals where Cancer Center personnel are not located. These are high risk subjects who do not yet have lung cancer. In addition, specialized training is required for the collection and handling of large numbers of specimens from each procedure at each visit. Special processing to allow separation of diagnostic tissue from remnant tissue and for cell culture is required. The Clinical Trials Core utilizes two databases. The SPORE Bioinformatics core provides a biorepository database that manages the storage and retrieval of biospecimens related to SPORE trials. This database also tracks all SPORE study subjects, enrollments, and personnel providing key statistics for grant reporting. The NCl?s Center for Bioinformatics provided our remote data capture management system in Oracle Clinical, and this provides a full suite of capabilities to facilitate study design, data entry, replication, and discrepancy management. We have a team of clinical research associates expertly trained to accrue subjects and collect data/tissue samples for all SPORE-supported trials. All data is entered into a web database designed to link the clinical information to the biological correlative studies for future analyses. During the previous five year funding period there have been 9 trials supported by the Clinical Trials Core and these trials have enrolled 720 subjects. Additional trials are being actively planned based on basic science and clinical discoveries. The CTC support has led to 34 publications involving all of the projects and to multiple vertical collaborations and subsequent trials

Public Health Relevance

The Clinical Trials core provides expertise to the principal investigators on each scientific project that will allow them to conduct translational research. Basic scientists can correlate their laboratory findings with clinical information to guide trial design. These novel trials focus on early detection, chemoprevention, and personalized therapeutic interventions that focus on specific genetic mutations.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Specialized Center (P50)
Project #
2P50CA058187-19A1
Application #
8664641
Study Section
Special Emphasis Panel (ZCA1-RPRB-7 (J1))
Project Start
Project End
Budget Start
2014-09-12
Budget End
2015-04-30
Support Year
19
Fiscal Year
2014
Total Cost
$261,822
Indirect Cost
$92,056
Name
University of Colorado Denver
Department
Type
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
Symonds, Jennifer M; Ohm, Angela M; Tan, Aik-Choon et al. (2016) PKCδ regulates integrin αVβ3 expression and transformed growth of K-ras dependent lung cancer cells. Oncotarget 7:17905-19
Dziadziuszko, Rafal; Le, Anh T; Wrona, Anna et al. (2016) An Activating KIT Mutation Induces Crizotinib Resistance in ROS1-Positive Lung Cancer. J Thorac Oncol 11:1273-81
Saichaemchan, S; Ariyawutyakorn, W; Varella-Garcia, M (2016) Fibroblast Growth Factor Receptors: From the Oncogenic Pathway to Targeted Therapy. Curr Mol Med 16:40-62
Scarborough, Hannah A; Helfrich, Barbara A; Casas-Selves, Matias et al. (2016) AZ1366: An inhibitor of tankyrase and the canonical Wnt pathway that limits the persistence of non-small cell lung cancer cells following EGFR inhibition. Clin Cancer Res :
Poczobutt, Joanna M; Nguyen, Teresa T; Hanson, Dwight et al. (2016) Deletion of 5-Lipoxygenase in the Tumor Microenvironment Promotes Lung Cancer Progression and Metastasis through Regulating T Cell Recruitment. J Immunol 196:891-901
Li, Bob T; Ross, Dara S; Aisner, Dara L et al. (2016) HER2 Amplification and HER2 Mutation Are Distinct Molecular Targets in Lung Cancers. J Thorac Oncol 11:414-9
Yoshida, Takeshi; Song, Lanxi; Bai, Yun et al. (2016) ZEB1 Mediates Acquired Resistance to the Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancer. PLoS One 11:e0147344
Ariyawutyakorn, Witthawat; Saichaemchan, Siriwimon; Varella-Garcia, Marileila (2016) Understanding and Targeting MET Signaling in Solid Tumors - Are We There Yet? J Cancer 7:633-49
Bunn Jr, Paul A; Minna, John D; Augustyn, Alexander et al. (2016) Small Cell Lung Cancer: Can Recent Advances in Biology and Molecular Biology Be Translated into Improved Outcomes? J Thorac Oncol 11:453-74
Helfrich, Barbara A; Kim, Jihye; Gao, Dexiang et al. (2016) Barasertib (AZD1152), a Small Molecule Aurora B Inhibitor, Inhibits the Growth of SCLC Cell Lines In Vitro and In Vivo. Mol Cancer Ther 15:2314-2322

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