Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06337097

Conditions

Immune Checkpoint Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Troponin surveillance

Standard of care

Study Details

Brief summary:

To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Conditions

Immune Checkpoint Therapy

Study ID

NCT06337097

Start date

Feb 2, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patient ≥18 years old
  • Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic
  • Willingness to provide informed consent

Exclusion Criteria:

  • Troponin T not available at screening or prior to randomization
  • Inability to comply with planned study procedures
  • Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment
  • Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study
  • Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Study Design

Enrollment

980 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Troponin Surveillance

Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.

experimental: Standard of Care

Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.

Interventions

Troponin surveillance

Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.

Standard of care

Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

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

(713) 606-3957nlpalaskas@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Nicolas Palaskas, MD

713-606-3957nlpalaskas@mdanderson.org

Principal Investigator:

Nicolas Palaskas, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.