Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07382752

Conditions

Tumor

Cardiovascular

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Tumor

Cardiovascular

Study ID

NCT07382752

Start date

Jan 9, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective Observational Cohort

Utilizing baseline biospecimens for analysis of predictors of cardiotoxicity events and cancer outcomes after ICI initiation.

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Nicolas Palaskas, MD

832-750-1109nlpalaskas@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Nicolas Palaskas, MD

832-750-1109nlpalaskas@mdanderson.org

Principal Investigator:

Nicolas Palaskas, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-16.