Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy 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
- 575
- 试验地点
- 1
- 主要终点
- Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy
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 peripheral neuropathy receiving chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to peripheral neuropathy.
详细描述
PRIMARY OBJECTIVES:
I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of peripheral neuropathy in patients of African and European descent in 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 and designated case or control
- •African American patients with DNA available and designated case or control status
- •Patients who developed grade 2-4 for African American (AA) and grade 3-4 for European American (EA) peripheral neuropathy during their treatment with paclitaxel and who did not develop peripheral neuropathy following a full course of treatment with paclitaxel
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 peripheral neuropathy
时间窗: Baseline
Assess by Burden analysis.
次要结局
未报告次要终点