Decoupling Immunotherapy Toxicity and Cancer Response
Purpose
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.
Conditions
- Tumor
- Cardiovascular
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years 2. Plan to start immune checkpoint inhibitor for cancer therapy
Exclusion Criteria
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Prospective Observational Cohort | Utilizing baseline biospecimens for analysis of predictors of cardiotoxicity events and cancer outcomes after ICI initiation. |
Recruiting Locations
Houston 4699066, Texas 4736286 77030
More Details
- NCT ID
- NCT07382752
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
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.