STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
ConditionImmune Checkpoint Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Troponin surveillance
Diagnostic testTroponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
Standard of care
Other interventionStandard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
Treatment groups
980 Participants
are divided into 2 treatment groupsGroup A: Troponin SurveillanceExperimental treatment 1 intervention
Group B: Standard of CareExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov