Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 169
- 试验地点
- 6
- 主要终点
- Myocardial extracellular volume (ECV)
研究概览
简要总结
This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations.
Safety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.
详细描述
The aim of this study is to identify and evaluate cardiotoxicity in patients with diagnosis of breast cancer, lymphoma or leukemia scheduled to receive anthracycline-based chemotherapy (Cohort A: prospective evaluation); and patients undergoing or having received within the last 5 years anthracycline-based chemotherapy (Cohort B: retrospective and prospective evaluations). Part A and B will be conducted in parallel. This study also has the objectif of identifying biomarkers of cardiotoxicity including inflammatory response proteins and clonal hematopoiesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age 18 years or older at time of CT initiation
- •Signed informed consent
- •Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects)
- •Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline
- •Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy
- •The participant is willing to undergo CMR scans and all other required study procedures
排除标准
- •Known cardiomyopathy and/or LVEF <50%
- •Known heart failure
- •History of myocardial infarction (MI)
- •Clinically significant cardiac valvular disease
- •Clinically significant pericardial effusion
- •Allografted subjects
- •Contraindications to CMR testing (Cohort A & prospective evaluation for Cohort B):
- •Pacemakers, other metallic implants or severe claustrophobia
- •Weight > 135 kg
- •Patients with a history of previous allergic reaction to gadolinium
- •Patients with history of seizure
- •Renal insufficiency (eGFR of < 45ml/min/1.73m2 using the MDRD equation)
- •Pregnant or breastfeeding women
结局指标
主要结局
Myocardial extracellular volume (ECV)
时间窗: Change from baseline to prior study entry, 12 and 24 months post study entry.
Cohort B
次要结局
- Left ventricular (LV) systolic function (global and regional)(Change from study entry to 12 and 24 months.)
- Biomarker of myocardial injury (high-sensitivity troponin (hs-cTn))(Change from study entry to 12 and 24 months.)
- Clonal hematopoiesis associated gene mutations.(Change from baseline to 24 months..)
- Biomarker of elevated LV fitting pressure (N-Terminal-pro-hormone B-type Natriuretic Peptide (NT-proBNP))(Change from study entry to 12 and 24 months.)
- Biomarker of inflammation (high-sensitivity C-reactive protein (hs-CRP))(Change from study entry to 12 and 24 months.)
- Telomere length measurement(Change from baseline to 24 months..)