Recruiting

NCT Number: NCT07382752

Decoupling Immunotherapy Toxicity and Cancer Response

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.

Recruiting

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Key information

Conditions

Tumor Cardiovascular Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Nicolas Palaskas, MD

CONTACT

[email protected]

832-750-1109

Nicolas Palaskas, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years
Plan to start immune checkpoint inhibitor for cancer therapy

Exclusion criteria

No baseline blood collection prior to initiation
At time of evaluation not determined to be a good candidate for evaluation of outcome events by the principal investigator

Treatment and study plan

Primary outcomes

Safety and Adverse Events (AEs)

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Palaskas, MD

CONTACT

[email protected]

832-750-1109

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2030
First posted: Feb 3, 2026
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting