Clinical Samples Core

Abstract The Clinical Core is integral to our CCRC’s activities coordinating and overseeing the access and distribution of biospecimens obtained from well characterized coccidioidomycosis patients to all investigators. This core will also provide regulatory support and, when necessary, assistance with study design and statistical analysis. This Core strengthens the coalition of expert clinical investigators with the fundamental aim of obtaining biospecimens and comprehensive clinical data from subjects with coccidioidomycosis. Our program has partnered with the two largest coccidioidomycosis clinical facilities in California: the Valley Fever Institute (VFI) affiliated with the Kern County Medical System and located in Bakersfield, the epicenter of coccidioidomycosis at the southern end of the California Central Valley; and the University of California Davis (UCD) Center of Excellence in Valley Fever, located at the northern end of the Central Valley. These two centers, and the skilled clinicians who run them, offer our program premier access to the key specimens and data needed to identify the genetic and immunological causes of disseminated coccidioidomycosis (DCM). Coordinating patient samples from two foremost institutions ensures a broadest variety of clinical phenotypes and diverse genomic ancestries of the patients drawn from across the Central Valley of the state of California, and a major strength of this Core is that the patient base we sample from will be among the largest and most diverse ever collected for coccidioidomycosis. We propose two straightforward aims in this core. First, in Aim 1, we will provide clinical samples and data. Biospecimens include blood and bronchoalveolar lavage specimens. Samples will be coded to de-identify. Phenotype information will be captured in an electronic clinical Case Report Form and stored in REDCap. This Core will work with the Administrative core to ensure oversight over samples. In Aim 2, the Clinical Core will ensure ethical approvals and human subjects approvals are all in place. Biosafety protocols for shipping and handling diagnostic specimens from patients will be developed and followed. The Clinical Core thus provides critical infrastructure and services for our research program to meet its goals for all Projects requiring human specimens.