Funded both intramurally and by external government agencies and commercial entities, SCIRC has a recognized obligation to fully disseminate the products of its research, consistent with its contractual assurances. To achieve these goals, SCIRC has teamed up with the Biorepository to serve as its “good faith” representative to administer the release of both deidentified data and archived biological samples.
About this archive
The SCIRC was created as a University of Florida-codified center in 2016 with the expressed goal to further our understanding of the immunological consequences of critical illness, particularly sepsis, trauma and perioperative injury.
For research funded by the Public Health Service and the Department of Health and Human Services, these agreements require that original de-identified clinical data and archived biological samples be made available to the general scientific community in a rapid and easily attainable manner.
Deidentified clinical data and archival samples will be released consistent with the policies of the CTSI Biorepository, and are independent of any input from SCIRC. These samples will be stored at the Biorepository and made available for researchers to use during and after the studies are completed. General policies regarding the requirement(s) for material transfer agreements, and any costs associated with the identification, removal and transport of biological samples are detailed in the CTSI Biorepository general policies.
Studies with available specimens
P50 GM-111182-05, PICS: A New Horizon in Surgical Critical Care
This is a prospective, observational long-term analysis of hospitalized patients with surgical sepsis 3135627. Data and blood samples were collected from a single-center prospective 1-year longitudinal cohort study (NCT02276417) of critically ill surgical patients.
The study included 363 septic patients hospitalized in a 48-bed surgical intensive care unit (ICU) at a quaternary care academic hospital between January, 2015, and January, 2020. Ethics approval was obtained from the University of Florida Institutional Review Board (#201400611). Informed consent was obtained from each subject or their surrogate decision-maker. Detailed study cohort design and protocols utilized by the University of Florida (UF) Sepsis and Critical Illness Research Center (SCIRC) program have been published previously 28765125, 24458039; Outcome variables included 30, 90, 180 day and one-year mortality, development of chronic critical illness and incidence of secondary infections. Clinical data, inflammatory mediator data, flow cytometry, and selected transcriptomic data are available.
Because the study was not prospectively designed to collect additional samples for archival, only a very limited number of blood samples are available.
GM-139046-01: Stratifying Patient Immune Endotypes in Sepsis (SPIES Study)
This is a prospective, observational, multicenter study (UF SCIRC, Washington University of St Louis, Department of Anesthesiology and the University of Cincinnati Department of Surgery) enrolling 270 patients with sepsis (using Sepsis-3 criteria) compared to 90 patients with critical illness without sepsis and 30 healthy subjects.
At 1, 4 and 7 days, and weekly thereafter post sepsis diagnosis, blood samples will be obtained and blood T-cell and monocyte production of IFN-gamma and TNF-alpha, respectively, will be determined by ELISpot. In addition, samples will be obtained for other biomarkers, including plasma proteins (IL-6 and sPD-L1), CD14+cell expression of HLA-DR, total lymphocyte count and whole blood genomics. Secondary infections will be the primary clinical index of outcome6, with secondary indices including hospital readmission, and 180 day mortality. In addition, we will evaluate in this ELISpot platform the ex vivo response of IFN-gamma production by T-cells and TNF-alpha production by monocytes stimulated with varying concentrations of IL-7, anti-PD-1 mAb, GITRL, OX40Lor 4-1BB, using a randomized block design. These immune stimulants are currently under consideration as potential therapeutics for sepsis patients. This application proposes the validation of a novel functional bioassay to identify patients who would benefit from immunotherapy, and to identify different immune therapies that would benefit the individual patient.
As of May 1, 2021, 42 subjects have been enrolled since enrollment began in January, 2021, and data and archived samples will be available after June 1, 2021.
GM-104481-04: Validation of a Genomics Based Prognostic in Severe Trauma
We propose that a significant proportion of patients who would generally meet the inclusion criteria for a study of severely injured patients, are not in need of immunomodulatory therapy and are not only unlikely to benefit but also suffer direct toxicity from such therapies. In contrast, there exists a subset of patients who are going to have a protracted clinical course, and would benefit from interventional therapies with biological‐response modifiers. We believe that we have developed such a prospective genomic test.
A prospective, observational cohort study of 127 severe trauma patients was conducted between October 2013 and August 2016 at 2 United States Level 1-trauma centers: SCIRC UFHealth Shands Hospital, Gainesville, Florida, and Harborview Medical Center, Seattle, Washington 30688688. The Institutional Review Board of each institution granted approval prior to study initiation, and signed informed consent was obtained from the patient and/or their legally appointed representative. The study was prospectively registered with clinicaltrials.gov (NCT 01810328). In the trauma cohort, EDTA-anticoagulated blood samples were collected within 12 hours and at 24 hours following the traumatic insult. Gene expression analysis was conducted on the NanoString nCounter gene expression platform (NanoString Flex) using a custom code set consisting of a 63-gene panel as previously described.
Clinical data, inflammatory mediator data, and selected transcriptomic data are available. Because the study was not prospectively designed to collect additional samples for archival, only a very limited number of blood samples are available.
How to access specimens
- Call or e-mail the CTSI Biorepository Client Coordinator, Erin Kelly, (352) 273-6138, email@example.com or email the Biorepository general email at Biorepository@pathology.ufl.edu
- Biorepository will provide an inventory report of available specimens as well as a quote for the cost of retrieving them
- Implement a Material Transfer Agreement between the University of Florida and your institution
- Submit a Statement of Work (SOW) for the specific specimens of interest
Additional considerations for researchers:
- Depending on the availability of specimens, there may be limitations on how many samples or volumes of each sample researchers can access
- All researchers may access these specimens after completing the appropriate steps for acquisition
CTSI Biorepository Client Coordinator | 352-273-6138
Researchers may also contact the Biorepository directly at Biorepository@pathology.ufl.edu