NCT05972343招募中不适用
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
研究概览
简要总结
This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Diagnosis of breast cancer.
- •Mass must be visible on ultrasound and > 5 mm from skin.
- •Not undergoing surgery, because:
- •Patient has a medical condition that would not allow sedation or general anesthesia
- •Surgery is not clinically indicated due to unresectable and/or metastatic disease
- •Surgery is not clinically indicated for another reason
- •Patient declines surgery
- •At least 18 years old.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- 未提供
结局指标
主要结局
Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
时间窗: Through 3 year follow-up
次要结局
- Proportion of patients who demonstrate progression-free survival (PFS)(At 3 year follow-up)
- Proportion of patients who demonstrate disease-free survival (DFS)(At 3 year follow-up)
- Proportion of patients who demonstrate overall survival (OS)(At 3 year follow-up)
研究者
研究点 (2)
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