NCT06337097招募中不适用
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Standard of Care
Experimental
Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.
干预措施: Standard of care (Other)
Troponin Surveillance
Experimental
Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.
干预措施: Troponin surveillance (Diagnostic Test)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
次要结局
未报告次要终点
研究者
研究点 (1)
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