Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
研究概览
简要总结
Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.
详细描述
The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims:
Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence.
Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must be ≥ 18 years of age.
- •histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer (American Joint Committee on Cancer, 7th edition stage 0, I, II, III, or IV) -previously treated with mastectomy
排除标准
- •pregnant or breast feeding.
- •cannot tolerate lying supine for breast ultrasound examination.
- •mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive microcalcifications in the absence of concurrent DCIS or invasive breast cancer
研究组 & 干预措施
Ultrasound
post mastectomy ultrasound
干预措施: post mastectomy ultrasound (Device)
结局指标
主要结局
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.
时间窗: 3 years
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound during a three year trial period.
次要结局
- The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured.(3 years)