NCT01452399已完成不适用
A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Optimal surgical treatment
研究概览
简要总结
This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.
- •Women ≥ 18 years of age.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have received previous neoadjuvant chemotherapy
- •Patients who require a total mastectomy
- •Known metastatic breast cancer.
结局指标
主要结局
Optimal surgical treatment
时间窗: 12 months
To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates
次要结局
- Cosmesis(12 months)
- Operative time(12 months)
- Volume of tissue resected(12 months)
研究者
研究点 (2)
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