Postoperative Identification of Tumor Cells At the Lumpectomy Site of Patients with Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Identification of Persistent Tumor Cells (PTCs)
研究概览
简要总结
For early breast cancer, local surgery followed by breast radiation is a standard local treatment. It has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. The researchers think that such relapse occurs because of persistent tumor cells (PTCs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. The researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. Results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 50 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with pathologic stage I to IIB invasive mammary breast cancer.
- •Tumor size over 1 cm.
- •Patient age 50 years or younger.
- •Primary tumor non-lobular.
- •Primary tumor non-low grade or Oncotype DX score >
- •Patient is six weeks or earlier post-lumpectomy.
- •Seroma is clinically palpable and symptomatic causing discomfort and/or swelling of the lumpectomy site OR re-excision of the lumpectomy site is planned.
排除标准
- 未提供
结局指标
主要结局
Identification of Persistent Tumor Cells (PTCs)
时间窗: Through study completion, an average of 2 years.
5 ml (one teaspoon) of fluid from the breast surgery site will be collected using a needle and syringe. This fluid will be sent to a laboratory in London Health Sciences Centre where it will be tested for the presence of cancer cells.
次要结局
未报告次要终点
