Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 693
- 试验地点
- 7
- 主要终点
- Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT
研究概览
简要总结
This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To collect biospecimens from 1) patients who developed chemotherapy related cardiac toxicity (CRCT) and 2) patients who are at a high risk for developing CRCT.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
- •One of the following:
- •Diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment
- •Completed chemotherapy with no cardiotoxicity at least two years post treatment
- •Patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity
- •An understanding of the protocol and its requirements, risks, and discomforts
- •The ability and willingness to sign an informed consent
排除标准
- •- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
研究组 & 干预措施
Observational
Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT
时间窗: Baseline
Assessed by the number of participants who participate and consent to have their specimen (blood draw) retained for future research.
次要结局
未报告次要终点