The Clinical Core for the University of Pittsburgh Cancer Institute (UPCI) Lung Cancer SPORE supports the infrastructure needed to satisfy the clinical research needs of the individual SPORE translational research projects. Fulfillment of SPORE translational research aims requires access to human subjects and associated clinical outcome information and biological materials (blood and tissue). In addition, successful completion of SPORE clinical trials and other interventions requires human research conducted according to exacting standards designed to protect research subjects from research risks. The Clinical Core provides the expertise and resources needed 1) to design and complete clinical trials, 2) to recruit, characterize, and follow human subjects for translational studies of laboratory-based cancer biomarkers, and 3) to obtain blood-based and tissue-based materials in support of clinical trials and biomarker research projects. To meet these objectives, the Clinical Core articulates the following four specific aims:
Specific Aim 1 : Design and implement clinical trials and clinical studies, Specific Aim 2: Identify, solicit, and enroll subjects into SPORE clinical trials, patient registries, and high risk cohorts, Specific Aim 3: Collect, manage, and store high quality risk factor and clinical outcome information, and Specific Aim 4: Deliver protocol-directed interventions and collect blood and tissue samples. The Clinical Core designs and implements clinical trials through the active participation of experienced clinical investigators. To enroll subjects into SPORE clinical studies, the Clinical Core integrates with local lung cancer treatment programs and with the Pittsburgh Lung Screening Study (PLuSS), an established high risk cohort containing over 3600 current and ex-cigarette smokers. In the renewal period, the Clinical Core proposes serial blood and sputum collections and additional computed tomography (CT) lung cancer screenings, restricted to an extreme high risk subset (N=1000-1100) of the PLuSS High-Risk Sub-Cohort. To collect and manage research data, Clinical Core investigators receive database management support through the Biostatistical/Bioinformatics Core and organize the activities of five stable institutionally approved generic research protocols pertaining to subject recruitment, data and biological sample collection, and follow-up. To deliver interventions and collect blood and tissue samples, the Clinical Core constitutes an organized team of cancer physicians, oncology protocol nurses, and laboratory technicians supported by the SPORE Blood and Tissue Core.
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