NCT05838001招募中不适用
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neo-adjuvant Therapy : a Prospective Randomized Control Trial.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Marginal positive rate
研究概览
简要总结
The standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, age≥18 year
- •A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
- •Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment.
- •Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery
排除标准
- •Inflammatory breast cancer or Paget's disease
- •Breast deformities and other conditions that impact breast conservation success rate
- •Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded.
- •Pregnancy or lactation
- •Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
- •Patients with stage IV diseases or unresectable lesions in either breast
- •Patients combined with other diseases that may affect survival
- •Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations
- •Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
- •Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy
结局指标
主要结局
Marginal positive rate
时间窗: up to 3 months
Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)
次要结局
- Re-operation rate.(up to 3 months)
- The proportion of breast-conserving surgery.(up to 3 months)
- IDFS(2 years, 3 years, and 5 years)
研究者
Chang Gong
Clinical Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (1)
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