Sapere Bio, Inc.

This is an observational study to discover risk factors of chemotherapy-induced peripheral neuropathy (CIPN) in 350 patients with early stage breast cancer undergoing taxane-based chemotherapy at two main sites (University of North Carolina at Chapel Hill (UNC) Hospital, including Rex Hospital, and the University of Alabama at Birmingham (UAB) Hospital). The primary purpose of this study to explore patient- and procedure-based variables that identify patients at risk for developing CIPN during chemotherapy.

This is a registry to identify changes in the expression of aging-related biomarkers, changes in functional performance, and/or changes in quality-of-life across the aging spectrum in 250 participants ≥ 25 years of age that will be conducted by the University of North Carolina. The primary purpose of this registry is to measure biomarkers of aging/senescence and build computational models of aging in order to better understand the role of senescence in aging-related functional decline and differences between aging in a general population vs cohorts enriched for aging related disease (cancer, heart disease). Aging biomarker data in cohorts with cancer and heart disease has already been collected; the current study will enroll participants into the cohort of aging in the general population (Aging Cohort).
Over the past century, life expectancy has increased by 30 years. With that gain has come a dramatic rise in age-related disease and an urgent need to understand, prevent, and treat these conditions. While age-related diseases have diverse phenotypes, there is increasing recognition of common biological underpinnings with cellular senescence as the nexus linking subcellular changes due to epigenetic changes, DNA damage, and mitochondria dysfunction with a decline in health due to multi-morbidity. The molecular changes that shift one's aging trajectory from a 'healthy' state to a 'disease' state are poorly understood; however, there is increasing evidence that senescence plays a key role in this shift. Computational models of natural aging and aging related disease are important tools in understanding the phenomenon of senescence, its regulation and dynamics, and its role in physiological or pathological processes during human aging. These findings will serve as pilot data for future analysis of cellular senescence, as measured by p16INK4 (hereafter referred to as p16) expression, and aging in other cohorts and begin to establish comparisons between p16 and other potentially clinically relevant aging biomarkers such as DNA methylation and plasma proteomics.

Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.
The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.