What this study is
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.
What's being tested
- Troponin surveillance
Intervention · DIAGNOSTIC TEST
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
- Standard of care
Intervention · OTHER
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
Study details
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Immune Checkpoint Therapy
- Enrolling
- 980 people
- Starts
- 2024-02-02
- Est. completion
- 2028-12-31
- Design
- Open-label, randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMD Anderson Cancer Center
Houston, Texas, United States
- Nicolas Palaskas, MD · Contact713-606-3957nlpalaskas@mdanderson.org
- Nicolas Palaskas, MD · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2023-1021
Principal investigator
Nicolas Palaskas, MD
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.