Life sciences · Observational Study
ClinicalTrials.gov · October 15, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07874698). This is a study registration, not published results. Lead sponsor: Unity Health Toronto. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Sepsis. Primary outcome measures: Percent accuracy of the SEPSET 6 gene classifier to predict clinical deterioration when compared to documented clinical deterioration in patients medical charts , 2 years. Brief summary: Sepsis is a complex syndrome that affects the functioning of multiple organ systems and is caused by an uncontrolled response to infection. Sepsis is usually diagnosed with a physical examination and evaluation of symptoms followed by lab tests to look at how different organ systems are functioning and to look for signs of infection, which can take up to 3 days. There aren't currently any tests that allow doctors to predict patient outcome, hospital course, or severity of illness. Our team has identified a set of genes that when combined can predict the likelihood of clinical deterioration; this set of genes is called SEPSET. In this study the investigators will evaluate the predictive capability of SEPSET along with clinical and laboratory measures in patients with suspected infection.