STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Troponin surveillance, Standard of care.
- Who it may be relevant to
- Registry conditions: Immune Checkpoint Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Primary Objectives:
* Myocarditis CTCAE version 5.0 grade ≥ 3 * Ventricular tachycardia (≥ 30 seconds) * Advanced atrioventricular block * Incident heart failure event * Cardiovascular mortality * Non-fatal sudden cardiac arrest * Acute coronary syndrome * Pericarditis * Pericardial tamponade
Secondary Objectives:
* Time from symptom onset to diagnosis of major adverse cardiovascular events * Time from symptom onset to diagnosis of myocarditis * Initial hospitalization duration for the adverse cardiovascular event from primary endpoint * Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band * Percentage of patients with negative workup for myocarditis * Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization * Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy * Cancer progression free survival * Time to next cancer therapy
Interventions
- Diagnostic test Troponin surveillance
Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy. - Other Standard of care
Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.
Primary outcome measures
- Safety and adverse events (AEs) [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06337097 · 2023-1021 · NCI-2024-02687