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临床试验/NCT01452399
NCT01452399已完成不适用

A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Yale University2 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2011年10月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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