The Clinical Trials Shared Resource (CTSR) is pivotal to the conduct of clinical research within the Duke Comprehensive Cancer Institute. This resource has evolved over the past 20 years from an embryonic oneperson protocol office to Its current staff of 16, centralizing protocol development, Protocol Review and Mooitoring-S-ystem-(HRMS)-admlni$tfation,-the Clinical-Trials-Quality-Assurance-and -Education-Program r and the Duke Comprehensive Cancer Institute (DCCI) Clinical Trials Office. The DCCI Clinical Trials Office Is a full-service operation offering start-to-finish clinical trials services to Cancer Institute members. The administrafive functions (protocol administration, PRMS administrafion, E-research database of protocols, pafient registrafion, quality assurance, safety surveillance desk and educafion of the CTSR stafl) are all centralized. All DCCl protocols, regardless of sponsorship, are processed through the CTSR Office for review by the PRMS and abstracted into the central database (E-research). All DCCI protocol subjects are registered through the CTSR Office and the disease site clusters for entry in E-research (average annual total accrual based on last five years: 5659 patients on therapeutic trials;14,420 subjects on non-therapeutic trials). Personnel providing start-up services are also housed in the CTSR Office. The Core Monitoring Team is staffed by members of the CTSR Office. Clinical trials operations are organized into disease and modalityspecific teams of Clinical Research Nurses (CRNs) and data managers (CRAs). The current teams, with total staffing over 100, are aligned with the existing programs of Breast and Ovarian Oncology, Experimental Therapeufics, Cancer Immunobiology, and Radiafion Oncology. The goal of the CTSR is to align its services in support ofthe scientific priorities ofthe Duke Comprehensive Cancer Insfitute. The CTSR is used mostly by peer-reviewed, DCCI members with highest priority given to peer-reviewed research. Charge-backs are on a sliding scale, with the biggest discounts provided to DCCl members conducfing peer-reviewed research.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Duke University
United States
Zip Code
Wu, Mengxi; Huang, Po-Hsun; Zhang, Rui et al. (2018) Circulating Tumor Cell Phenotyping via High-Throughput Acoustic Separation. Small 14:e1801131
Vlahovic, Gordana; Meadows, Kellen L; Hatch, Ace J et al. (2018) A Phase I Trial of the IGF-1R Antibody Ganitumab (AMG 479) in Combination with Everolimus (RAD001) and Panitumumab in Patients with Advanced Cancer. Oncologist 23:782-790
Xu, Yinghui; Liu, Hongliang; Liu, Shun et al. (2018) Genetic variant of IRAK2 in the toll-like receptor signaling pathway and survival of non-small cell lung cancer. Int J Cancer 143:2400-2408
Feng, Yun; Wang, Yanru; Liu, Hongliang et al. (2018) Novel genetic variants in the P38MAPK pathway gene ZAK and susceptibility to lung cancer. Mol Carcinog 57:216-224
Naqvi, Ibtehaj; Gunaratne, Ruwan; McDade, Jessica E et al. (2018) Polymer-Mediated Inhibition of Pro-invasive Nucleic Acid DAMPs and Microvesicles Limits Pancreatic Cancer Metastasis. Mol Ther 26:1020-1031
Wen, Juyi; Liu, Hongliang; Wang, Lili et al. (2018) Potentially Functional Variants of ATG16L2 Predict Radiation Pneumonitis and Outcomes in Patients with Non-Small Cell Lung Cancer after Definitive Radiotherapy. J Thorac Oncol 13:660-675
Li, Bo; Wang, Yanru; Xu, Yinghui et al. (2018) Genetic variants in RORA and DNMT1 associated with cutaneous melanoma survival. Int J Cancer 142:2303-2312
Gearhart-Serna, Larisa M; Jayasundara, Nishad; Tacam Jr, Moises et al. (2018) Assessing Cancer Risk Associated with Aquatic Polycyclic Aromatic Hydrocarbon Pollution Reveals Dietary Routes of Exposure and Vulnerable Populations. J Environ Public Health 2018:5610462
Bakthavatsalam, Subha; Sleeper, Mark L; Dharani, Azim et al. (2018) Leveraging ?-Glutamyl Transferase To Direct Cytotoxicity of Copper Dithiocarbamates against Prostate Cancer Cells. Angew Chem Int Ed Engl 57:12780-12784
Dai, Ziwei; Mentch, Samantha J; Gao, Xia et al. (2018) Methionine metabolism influences genomic architecture and gene expression through H3K4me3 peak width. Nat Commun 9:1955

Showing the most recent 10 out of 513 publications