NCT07382752

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Jun 2030

Study Start

First participant enrolled

January 9, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

TumorCardiovascular

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (1)

Prospective Observational Cohort

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MD Anderson Cancer Center

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Nicolas Palaskas, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Palaskas, MD

CONTACT

832-750-1109nlpalaskas@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

January 9, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2030

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

US(1)