RecruitingNot ApplicableNCT06337097
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
Sponsor
M.D. Anderson Cancer Center
Enrollment
980 participants
Start Date
Feb 2, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria5
- 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.
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Interventions
DIAGNOSTIC_TESTTroponin surveillance
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
OTHERStandard of care
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06337097
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