Separating heart side effects from cancer benefit of immunotherapy
Official title: Metabolomic and Genetic Factors Decoupling Immune Checkpoint Inhibitor Tumor Efficacy and Cardiovascular Toxicity
Run by M.D. Anderson Cancer Center · NCT07382752 · Data updated 2026-11-12
This project will try to find which adults starting immune checkpoint inhibitors are likely to have heart problems versus cancer benefit by testing blood markers like metabolomics, CHIP, and epigenetic aging.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | January 9, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2030 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07382752 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who plan to start immune checkpoint inhibitor therapy and can provide a baseline blood sample before treatment are the intended participants.
✕Probably not a fit
Patients who cannot provide a baseline blood sample before starting treatment or who are judged by the principal investigator not to be appropriate candidates for outcome evaluation would not be eligible and likely would not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll adults starting immune checkpoint inhibitor (ICI) therapy and collect baseline blood samples prior to treatment. Researchers will analyze metabolomic signatures from human monocyte-derived macrophages, clonal hematopoiesis of indeterminate potential (CHIP) variants, and epigenetic aging measures and then follow patients for ICI-associated cardiovascular disease (ICI-CVD), cancer progression, or death. The primary goal is to identify predictors of a composite outcome of ICI-CVD and cancer progression or death and to distinguish predictors specific to cardiotoxicity versus cancer response. The work is single-center and does not involve experimental treatments or changes to standard cancer therapy.
Why it matters
Potential benefit: If successful, this work could help doctors predict who is at higher risk of heart side effects from immunotherapy and personalize monitoring or treatment plans to protect the heart while preserving cancer benefit.
How similar studies have gone: Some components such as CHIP and metabolomic links to cardiovascular risk have supporting data, but combining CHIP, epigenetic aging, and HMDM-derived metabolomics to decouple ICI cardiotoxicity from cancer response is a novel approach with limited prior direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Nicolas Palaskas, MD — M.D. Anderson Cancer Center
- Study coordinator: Nicolas Palaskas, MD
- Email: nlpalaskas@mdanderson.org
- Phone: 832-750-1109
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cardio-Metabolic Clinic care for adults with type 2 diabetes and cardiovascular disease
This trial tests whether a specialized Cardio-Metabolic Clinic can improve heart function and overall health for adults with type 2 diabetes and cardiovascular disease compared with usual care.
-
Petrelintide for weight loss in people with overweight/obesity and heart disease
This study tests whether petrelintide helps people with overweight or obesity and cardiovascular disease lose weight when added to a reduced-calorie diet and more physical activity, compared with a placebo.
-
VERVE-102 for adults with or at high risk for heart disease
This study tests whether VERVE-102 can lower bad cholesterol (LDL-C) compared with a placebo in adults with plaque buildup or high risk for it.
-
Clazakizumab for adults with high hsCRP at risk for a heart event
This study tests whether clazakizumab can lower inflammation and reduce cardiovascular risk in adults with high hsCRP and existing risk factors.
-
Improving Care for underserved older Black patients with cardiovascular and other chronic conditions
This study tests a culturally tailored approach to patient-centered care for older African American patients with cardiovascular disease and other conditions who receive care at a community hospital.
-
4D MRI parameters linked to cardiovascular and cancer disease outcomes
This study tests whether 4D MRI measurements can predict how cardiovascular diseases and cancer will progress in adults undergoing routine cardiac MRI at a single Korean hospital.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.