Exploratory Next Generation Sequencing to Identify Causative Variants for Therapy-Induced Congestive Heart Failure From Breast Cancer Study E5103 Germline DNA Samples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Identification of rare coding variants of large effect that predict the risk of CHF
研究概览
简要总结
This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.
详细描述
PRIMARY OBJECTIVES:
I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of congestive heart failure (CHF) in patients from the clinical trial ECOG-5103 (E5103).
OUTLINE:
Previously collected germline DNA samples are analyzed via whole exome sequencing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •European American patients with DNA available
- •European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab
- •African American cases (based on a drop in left ventricular ejection fraction [LVEF] < 50 or a drop from baseline > 20 points) and African American controls
排除标准
- 未提供
结局指标
主要结局
Identification of rare coding variants of large effect that predict the risk of CHF
时间窗: Baseline
Assessed by burden analysis.
次要结局
未报告次要终点