Precision Medicine Center for Cystic Fibrosis

University Of Iowa, Iowa City IA

Investigators

Linked publications & trials

Abstract

ABSTRACT/PROJECT SUMMARY (CLINICAL PHENOTYPING CORE – CORE 3) The Clinical Phenotyping Core (Core 3) has a single overarching goal: to facilitate rapid translation of basic science research/pre-clinical work to human cystic fibrosis (CF), CF carrier, and non-CF (control) subjects and samples. The Core was established to address two major limitations: 1) knowledge gaps in in relating basic science to clinical human subjects’ data and 2) access of basic scientists to human samples. Together these core issues create a major barrier to translation of basic findings (especially disease pathophysiology) to humans with CF. The Core supports rapid translation of basic CF research by providing CF investigators access to both banked and prospectively acquired human biospecimens through the following three aims: (1) Proactively facilitate the recruitment of CF, carrier, and non-CF subjects to investigator-driven clinical trials. The Core assists basic and translational researchers in obtaining specific biological samples that are not routinely banked and it aids in conducting clinical trials, including clinical study design and statistical support, preparing IRB submissions, recruiting participants, performing specialized procedures, and ensuring that clinical research is conducted in accordance with the principles of Good Clinical Practice (GCP). (2) Organize, maintain, and support an electronic and physical biobank of CF, carrier, and non-CF human specimens collected during routine clinical visits and clinical trials. The Core provides and supports a centralized database of CF, carrier, and non-CF bio samples, and prospectively archives biosamples of general utility to investigators performing clinical/translational research. The Core obtains and maintains active consent for sample biobanking from people with CF (pwCF), people with CF-associated symptoms not currently diagnosed; acquires and maintains CF and non-CF specimens including DNA, bronchoalveolar lavage fluid (BALF), sputum, whole blood, plasma, serum, feces, urine, tissue from surgical and autopsy samples, and bacterial isolates, (including molecular typing of bacterial and other isolates when available); maintains databases of historical clinical samples and prospectively collected samples; and maintains and improves a standardized process through which investigators can obtain de-identified or identified clinical information from archived clinical samples or samples obtained prospectively during routine clinical bloodwork. (3) Provide a portal through which investigators can obtain clinical information on archived and prospectively collected biosamples. The Core assists investigators in obtaining de-identified clinical information (or identifiable information as approved by the IRB) from CF, carrier, and non-CF human subjects, including both subjects with extant samples in the biobank and subjects whose samples require prospective collection. Information from ongoing clinical trials within the Center, or supporting unique research needs, may be provided as needed with appropriate IRB approval. The biobank has standardized consent in place for >70% of people who are seen for CF at UI, and thus facilitates rapid investigator access to samples and linked clinical information.