Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Sensitivity of each biomarker for detecting cardiotoxicity
研究概览
简要总结
This trial studies how well cardiac biomarkers work in the early detection of cardiotoxicity in patients receiving sunitinib malate or sorafenib chemotherapy. Some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. Often, the damage is not detected until heart failure has already occurred. Testing for cardiac biomarkers, such as troponin I and/or T and B-type natriuretic peptide (BNP), may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram).
详细描述
PRIMARY OBJECTIVES:
I. To determine if specific biomarkers (troponin I and B-type natriuretic peptide [BNP]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy.
SECONDARY OBJECTIVES:
I. To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18-85 years
- •Starting a new course of chemotherapy at MD Anderson Cancer Center that includes sunitinib or sorafenib
- •Has a life expectancy of greater than 6 months
排除标准
- •Unstable angina within the last 3 months
- •Myocardial infarction within the last 3 months
- •Left ventricular ejection fraction (LVEF) less than 40%
- •Decompensated heart failure (HF) in the last 3 months
结局指标
主要结局
Sensitivity of each biomarker for detecting cardiotoxicity
时间窗: Up to 6 months
Will estimate with exact 95% confidence intervals.
Specificity of each biomarker for detecting cardiotoxicity
时间窗: Up to 6 months
Will estimate with exact 95% confidence intervals.
次要结局
- MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score(Up to 6 months)
- Incidence of cardiotoxicity(Up to 6 months)