A Retrospective Analysis of the Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of DPYD variants in patients
研究概览
简要总结
The goal of this laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery. Researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine.
详细描述
If you agree to take part in this study, 1 blood sample (about 2 tablespoons) will be drawn for use in genetic research.
If you are unable to provide a blood sample, researchers will collect leftover tissue samples from your previously collected tumor tissue (from the time of the breast cancer diagnosis). The tumor samples will be used for genetic research.
After the blood draw or tissue collection, your participation in this study will be over.
The blood samples for the genetic research will be stored at Myriad Laboratories. Before your blood and/or tissue is sent to Myriad Laboratories for banking, your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by Myriad Laboratories for additional research.
This is an investigational study. Up to 210 patients will take part in this study. All will be enrolled at M. D. Anderson.
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
- •Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study.
- •Patients must sign an informed consent for this protocol.
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Incidence of DPYD variants in patients
时间窗: 2 Years
次要结局
未报告次要终点