CLINICAL CORE

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Linked publications & trials

Abstract

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