The Clinical Protocol Office (CPO) is a UNC Lineberger shared resource that is widely used by members from various disciplines to perform translational and clinical research using patient populations at the Center and its affiliates. The CPO has centralized the protocol registration and management of all institutional clinical trials at UNC into a single office. Dr. Thomas Shea is the Faculty Director and Libby Anderson, R.N., M.Ed., protocol activities; provide resources to individual investigators to facilitate approval of UNC/LCCC sponsored clinical research; and oversee the conduct of cancer clinical trials at UNC. The CPO also now offers coordination services for multi-center studies including study initiation activities, planning of investigator meetings, regulatory documents management, case report management, case report form development, multi-center data coordination and clinical research monitoring. The existing staff of 23 supports 258 active trials with approximately 400 protocol patients currently being treated. In addition, through the Biostatistics Core Facility, the CPO has the services of biostatisticians (Michael Schell, Ph.D., Bahjat Qaqish, M.D., Ph.D., and two Masters- level biostatisticians) who provide input in the maintenance of the Cancer Center database and expertise in the design of clinical studies. Approximately 1,039 protocol patients are managed for follow-up by current staff. In 1998, the CPO assisted in the initiation of 92 new protocols. The activity of the Clinical Protocol Office continues to increase. Accrual to treatment protocols has increased from 188 in 1993 to 347 in 1998. UNC patient accrual to all trials totaled 474 in 1998. Over 300 additional patients (311) were enrolled through the UNC affiliate network, resulting in a total of 785 patients enrolled onto clinical trials under the auspices of the UNC LCCC. Patient accrual to institutional treatment trials has increased almost three fold in the last five years, rising from 66 in 19993 to 190 in 1998. Minority accrual to all trials has remained steady at approximately 27 percent (annual range 20-33%). In 1998, a total of 43 Cancer Center members used the Clinical Protocol Office to open, amend, or renew a protocol, or take some other action. The 43 members, plus 10 additional non members, accounted for 581 actions, with Center members accounting for 567 (97%) actions. The non- member activity was generated by fellows or faculty working on collaborative projects with Center members. The UNC Lineberger Clinical Protocol Office is the focal point for development and initial of clinical cancer trials at UNC. During the last four years, new leadership has been put in place, substantial institutional resources have been committed, and the clinical research program has grown significantly. Continued expansion of the CPO will be necessary during the next five years as the Center, the School of Medicine, and the UNC Hospitals continue their emphasis on clinical research and oncology. Several projects intended to meet these needs are under way including improvement of the Web site for the Protocol Office to provide information regarding ongoing studies, updating or existing clinical trials management databases, and development of a formalized network of clinical trial sites for participation in institutional trials coordinated by the UNC CPO. These are a few examples of how the Clinical Protocol Office continues to seek new ways of meeting the needs of the Cancer Center members and protocol patients it serves.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA016086-25
Application #
6398598
Study Section
Project Start
2000-05-01
Project End
2000-11-30
Budget Start
Budget End
Support Year
25
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Suzuki, Aussie; Long, Sarah K; Salmon, Edward D (2018) An optimized method for 3D fluorescence co-localization applied to human kinetochore protein architecture. Elife 7:
Mohan, Vishwa; Sullivan, Chelsea S; Guo, Jiami et al. (2018) Temporal Regulation of Dendritic Spines Through NrCAM-Semaphorin3F Receptor Signaling in Developing Cortical Pyramidal Neurons. Cereb Cortex :
Haase, Karen P; Fox, Jaime C; Byrnes, Amy E et al. (2018) Stu2 uses a 15-nm parallel coiled coil for kinetochore localization and concomitant regulation of the mitotic spindle. Mol Biol Cell 29:285-294
Nicholls, Thomas J; Nadalutti, Cristina A; Motori, Elisa et al. (2018) Topoisomerase 3? Is Required for Decatenation and Segregation of Human mtDNA. Mol Cell 69:9-23.e6
Becker, Silke; Wang, Haibo; Simmons, Aaron B et al. (2018) Targeted Knockdown of Overexpressed VEGFA or VEGF164 in Müller cells maintains retinal function by triggering different signaling mechanisms. Sci Rep 8:2003
Kim, R D; Alberts, S R; Peña, C et al. (2018) Phase I dose-escalation study of copanlisib in combination with gemcitabine or cisplatin plus gemcitabine in patients with advanced cancer. Br J Cancer 118:462-470
Chiang, Yun-Chen; Park, In-Young; Terzo, Esteban A et al. (2018) SETD2 Haploinsufficiency for Microtubule Methylation Is an Early Driver of Genomic Instability in Renal Cell Carcinoma. Cancer Res 78:3135-3146
Reuland, Daniel S; Cubillos, Laura; Brenner, Alison T et al. (2018) A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak 18:5
Kornides, Melanie L; McRee, Annie-Laurie; Gilkey, Melissa B (2018) Parents Who Decline HPV Vaccination: Who Later Accepts and Why? Acad Pediatr 18:S37-S43
Ramsingh, Arlene I; Gray, Steven J; Reilly, Andrew et al. (2018) Sustained AAV9-mediated expression of a non-self protein in the CNS of non-human primates after immunomodulation. PLoS One 13:e0198154

Showing the most recent 10 out of 1525 publications