The Comprehensive Cancer Center of Wake Forest University (CCCWFU) Community Clinical Oncology Program (CCOP) Research Base was funded in 9/99 (retroactive to 6/99) for three years. This application describes the administrative structure, including safety and monitoring procedures and clinical research activities of the Research Base for its five-year competitive renewal as a control/treatment CCOP Research Base. Participants in the Research Base include three CCOPs (Southeast Cancer Control Consortium, Winston-Salem, NC; Upstate Carolina CCOP, Spartanburg, SC; Greenville CCOP, Greenville SC) and four non-CCOP Prevention Members (East Carolina University, Greenville, NC; High Point Regional Health System, High Point, NC; InterCommunity Cancer Center, Rome, GA; WakeMed System, Cary, NC. The geographic region covered by these three CCOPs and four Prevention Members includes seven states (NC, SC, VA, WV, KY, TN, GA) with a population of approximately 12 million people, one-quarter of whom are minorities (60% minorities in coastal NC communities), served by 28 cancer centers. It is anticipated that an additional 3-6 CCOPs and Minority-Based CCOPs will join the CCCWFU CCOP Research Base by 12/01. Active and developing clinical trials of the Research Base are described in the application. In cancer control, there are 4 active and 13 developing studies, focusing on the following areas: complimentary and alternative medicine, symptom management, and quality of life, particularly in the setting of cancer related fatigue, anorexia/weight loss, depression, hot flashes, cognition and chemoprevention. In cancer treatment, there are 6 active and 7 developing studies, focusing on complementary, alternative, and conventional therapies primarily in lung, pancreas, and brain cancer. The spectrum of clinical research studies offered by the CCCWFU CCOP Research Base is complementary to, rather than competitive with, the cancer control/treatment protocols offered by the Cooperative Group Research Bases. Under the direction of Principal Investigator Edward G. Shaw, M.D., the Clinical Research Management administrative structure of the CCCWFU, and key leadership from the CCCWFU, CCOPs, and Prevention Members, the CCCWFU CCOP Research Base is fulfilling its primary goal of providing state-of-the-art intervention oriented clinical research studies in cancer prevention/control to CCOPs and patients (including minorities) in the Southeast United States.
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