Metabolomic and Genetic Factors Decoupling Immune Checkpoint Inhibitor Tumor Efficacy and Cardiovascular Toxicity

What this Trial Is About

This research aims to identify factors that predict cardiovascular disease related to immune checkpoint inhibitor (ICI) therapy and to distinguish these from factors that influence cancer treatment outcomes. The study focuses on traditional cardiovascular risk factors, metabolomic profiles, epigenetic aging, and clonal hematopoiesis of indeterminate potential (CHIP) in patients receiving ICI therapy. It is not an extension of previous work but a novel evaluation in this area. Participants will provide baseline blood samples before starting ICI therapy, which researchers will analyze to find metabolite signatures from human monocyte derived macrophages (HMDM) and genetic and epigenetic markers that may predict cardiovascular toxicity and cancer outcomes. The study observes patients over time without assigning interventions, following a prospective observational cohort design. During the study, participants will be monitored for safety and adverse events, with an average follow-up of about one year. Researchers will review outcomes related to cardiovascular disease and cancer progression or death. The study involves blood collection at baseline, and ongoing evaluations to understand how genetic and metabolomic factors relate to treatment effects and side effects over the study period, which runs through June 2030.

Decoupling Immunotherapy Toxicity and Cancer Response