NCT07382752Recruiting

Decoupling Immunotherapy Toxicity and Cancer Response

M.D. Anderson Cancer Center

Start Date

1/9/2026

Completion Date

6/30/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age ≥ 18 years 2. Plan to start immune checkpoint inhibitor for cancer therapy Exclusion Criteria: 1. No baseline blood collection prior to initiation 2. At time of evaluation not determined to be a good candidate for evaluation of outcome events by the principal investigator

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Conditions

TumorCardiovascular

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas 77030

United States