NCT07382752

Decoupling Immunotherapy Toxicity and Cancer Response

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a novel evaluation of cardiotoxicity after ICI therapy based on traditional CV risk factors with the addition of metabolomic profiles, epigenetic aging, and CHIP. It is not an extension of previous work in ICI therapy.

Detailed description

Primary Objectives: To identify predictors of a composite outcome comprising immune checkpoint inhibitor associated cardiovascular disease (ICI-CVD) and/or cancer progression or death. To decouple the predictors of ICI-CVD and cancer treatment efficacy. Secondary Objectives: To identify human monocyte derived macrophages (HMDM)-derived metabolite signatures predictive of cardiovascular toxicity and cancer outcomes in ICI-treated patients. To identify genetic (CHIP) and epigenetic age determinants of ICI-CVD and cancer outcomes in ICI-treated patients.

Conditions

• Tumor
• Cardiovascular

Timeline

• Start date: 2026-01-09
• Primary completion: 2028-06-30
• Completion: 2030-06-30
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States