The Clinical Protocol Office (CPO) is the coordinating center for all UNC Lineberger Comprehensive Cancer Center sponsored local and multi-center trials and the majority of Cooperative Group and pharmaceutical company supported cancer research. The CPO consists of 30 professionals responsible for assisting in protocol development, contract acquisition and management, regulatory oversight and compliance, 9reparation and submission of INDs for novel studies and novel compounds, internal and external study tudits and quality control, and data acquisition and preparation, and management. Since the last critique, the CPO has implemented the ProTrack database, an effective and reliable data storage and retrieval system for managing clinical trials. This database facilitates the timely and accurate submission of numerous INDs to the FDA, as well as expansion of capacity for managing novel institutional and multi-center studies. At the urging of external advisors, the Center has also added a Protocol Office Executive Committee that provides oversight, advice, and direction for policy, study prioritization, and resource allocation. These improvements plus continued staff expansion have enabled the CPO to support increasinly complex, innovative studies such as the Phase I bortezomib (LCCC 9804), a GSK sponsored EGFR trials, and multi-center, Phase III studies such as LCCC 9719. Mark Socinski, MD is the CPO Faculty Director; Joy Ostroff, RN, BBSN, OCN, is the Facility Director. The CPO reports to Dr. Richard Goldberg, Associate Director for Clinical Research. The majority of the proposed increase provides infrastructure to support increased quality (including audit), growing demands for regulation and oversight, and accrual outreach, particularly to minorities.

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
University of North Carolina Chapel Hill
Chapel Hill
United States
Zip Code
McNeill, Robert S; Stroobant, Emily E; Smithberger, Erin et al. (2018) PIK3CA missense mutations promote glioblastoma pathogenesis, but do not enhance targeted PI3K inhibition. PLoS One 13:e0200014
Graham-Gurysh, Elizabeth; Moore, Kathryn M; Satterlee, Andrew B et al. (2018) Sustained Delivery of Doxorubicin via Acetalated Dextran Scaffold Prevents Glioblastoma Recurrence after Surgical Resection. Mol Pharm 15:1309-1318
Trout, Susan; Goldstein, Adam O; Marks, Lawrence et al. (2018) Treating Tobacco Use in Patients with Incurable Malignancies: Should We Even Start the Conversation? J Palliat Med 21:746-750
Lee, Clara Nan-Hi; Pignone, Michael Patrick; Deal, Allison M et al. (2018) Accuracy of Predictions of Patients With Breast Cancer of Future Well-being After Immediate Breast Reconstruction. JAMA Surg 153:e176112
Ricketts, Christopher J; De Cubas, Aguirre A; Fan, Huihui et al. (2018) The Cancer Genome Atlas Comprehensive Molecular Characterization of Renal Cell Carcinoma. Cell Rep 23:313-326.e5
Golden, Shelley D; Kong, Amanda Y; Lee, Joseph G L et al. (2018) Disparities in cigarette tax exposure by race, ethnicity, poverty status and sexual orientation, 2006-2014, USA. Prev Med 108:137-144
Song, Wantong; Shen, Limei; Wang, Ying et al. (2018) Synergistic and low adverse effect cancer immunotherapy by immunogenic chemotherapy and locally expressed PD-L1 trap. Nat Commun 9:2237
Kaur, Gurpreet; Guruprasad, Kunchur; Temple, Brenda R S et al. (2018) Structural complexity and functional diversity of plant NADPH oxidases. Amino Acids 50:79-94
Moore, Patrick J; Reidel, Boris; Ghosh, Arunava et al. (2018) Cigarette smoke modifies and inactivates SPLUNC1, leading to airway dehydration. FASEB J :fj201800345R
Anders, Penny M; Montgomery, Nathan D; Montgomery, Stephanie A et al. (2018) Human herpesvirus-encoded kinase induces B cell lymphomas in vivo. J Clin Invest 128:2519-2534

Showing the most recent 10 out of 1525 publications