Core--Clinical

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DESCRIPTION (provided by applicant): Clinical interaction with patients and health care providers is crucial to the success of each research study proposed within the SPORE, and to the long-term success of a translational program of ovarian cancer research. The primary aim of the Clinical Core is to provide the clinical expertise, including physician and patient interaction that is necessary for the successful completion of the research objectives of the SPORE studies and potential pilot activities. The POCRC Clinical Core has a proven track record in recruiting, from a broad array of facilities, large cohorts of women at risk for developing ovarian cancer (pre-diagnosis cohort) and women with ovarian cancer at the time of diagnosis (incident cases cohort) and during treatment and follow-up (post diagnosis cohort). Using uniform protocols to approach, consent, enroll and track participants over 1200 women have been enrolled into POCRC SPORE (n=506) inter-SPORE collaborations (n=177) and investigator initiated RO1 funded (n= 592) ovarian cancer research projects. Clinical, pathological and epidemiological data are collected from all participants using standardized data collection instruments. The Clinical Core also includes a Physicians Advisory Committee (PAC) and a Patient Advocacy Group (PAG). The PAC works to ensure that as many participants as possible are included in the research and that the goals and progress of the research are disseminated into the clinical community. The Patient Advocacy Group works directly with researchers at all levels of the SPORE program ensuring that ovarian cancer patients are represented in all phases of the research, particularly those that involve interactions with patients and women at risk for ovarian cancer. Although successful, it is essential that the Clinical Core evolve to meet the changing focus of our SPORE program. Specifically we are proposing to incorporate the following within the existing Core 1) a Clinical Trials Research Support Network to facilitate the conduct of our Phase I trials of immunotherapy and ovarian cancer screening and the translation of therapeutic strategies resulting from laboratory based investigations into Phase I human clinical trials; and 2) a minority outreach network to increase enrollment of minority women into the research program.