Cardiovascular, Tumor
Conditions
Brief 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.
Interventions
None listed
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTNicolas Palaskas, MD
PRINCIPAL_INVESTIGATORNicolas Palaskas, MD
M.D. Anderson Cancer Center
Outcome results
None listed