Clinical Core - Core 1 - Brewington

PROJECT SUMMARY / ABSTRACT A foundational component of this P30 application is the Personalized Clinical Core, which spans Cincinnati Children's Hospital Medical Center (CCHMC), University of Cincinnati (UC), and Cedars Sinai Medical Center (CSMC). With the primary site at CCHMC, this core leverages strengths in CFTR biology, clinical trials, and translational research across the three campuses. This extended core will be the primary interface with clinical research and patient care, and will serve as a source of human cells, tissues, biofluids [e.g.: sputum, bronchoalveolar lavage fluid (BALF), sweat, serum] and translational research expertise (including established and emerging physiologic, CFTR, and pulmonary imaging measures). These samples will be essential for furthering personalized care in CF and for understanding extra-pulmonary manifestations of the disease. The Personalized Clinical Core builds on existing research infrastructure, including the CFF-TDN program, the CFRDP program, investigator-initiated research, and institutional commitments to CF translational research at all three sites. The Personalized Clinical Core will expand these capabilities in critical ways, focusing on obtaining relevant patient-derived biospecimens accompanied by clinical correlates, and providing full clinical research capabilities to operationalize novel translational research projects. Samples are retained locally (CSMC or CCHMC), but freely shared across core sites using common SOPs and regulatory infrastructure. In addition, this core supports translational study through design consultation, statistical support, and advanced outcome measures, facilitating the translation of laboratory findings into early patient trials. The vision of this P30 Core is to enhance the CF-focused research on campus and beyond by the provision of well-characterized, high-quality human samples from CF patients and appropriate non-CF controls, coupled with clinical trial expertise specific to the needs of CF researchers. Centralizing these capabilities through the Personalized Clinical Core will increase research efficiency and standardization. All samples obtained and processed through the Personalized Clinical Core will be available for direct use by CF researchers, and for projects utilizing the Personalized Model Systems Core, the CF Related Disease Model Core, and the P&F Core.