Integrated Basis and Translational Approaches to Identify Early Biomarkers and Pathogenesis of Anthracycline Cardiotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- CMR
研究概览
简要总结
Early microRNAs (miRs) and Cardiac Magnetic Resonance (CMR)-derived strain analysis and detection of genes contributing to Anthracycline-Induced Cardiotoxicity (AIC) sensitivity and resistance will identify pediatric cancer patients most and least likely to develop AIC.
详细描述
Plan is to enroll 110 children and adults (≥9 years old) newly diagnosed at CCMC and Nationwide Children's Hospital (55 per institution) who will receive anthracyclines as part of their chemotherapy regimen.
The duration of study participation will be approximately a year.
Patients will have a total of four study visits:
Baseline
1 week after patient's anthracycline cumulative dose hits between 60 and 100 mg/m2 After the patient has completed maximal therapy One year after completion of anthracycline treatments
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (≥ 9years old)
- •Newly diagnosed with a malignancy that will receive ACs as part of their chemotherapy.
- •Parental/caregiver consent and subject assent to enrollment.
排除标准
- •Subject has contraindications to CMR.*
- •Subject requiring sedation for CMR
- •Subject too large to be safely accommodated by CMR
- •Pregnancy tests are done routinely prior to chemotherapy, if test is positive the patient will be excluded
- •Subject's serum creatinine above guidelines for adequate renal function. See table below:
- •Age (years) Male Female 6-10 1.0 mg/dL 1.0 mg/dL 10-13 1.2 mg/dL 1.2 mg/dL 13-16 1.5 mg/dL 1.4 mg/dL >16 1.7 mg/dL 1.4 mg/dL
结局指标
主要结局
CMR
时间窗: From Baseline to one year after anthracycline therapy
1\. Increased myocardial T2 relaxation time in the myocardium compared to baseline as measured by T2 mapping technique
次要结局
未报告次要终点