Diagnostic accuracy of surgical margin obtained through gross examination of the specimen in predicting margin negativity among patients undergoing Breast conservative surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To assess the diagnostic utility of surgical margin obtained through
研究概览
简要总结
Diagnostic accuracy of surgical margin obtained through
intraoperative gross examination of the specimen in predicting
margin negativity among patients undergoing Breast conservative
surgery, A observational study- single institute study with primary outcome being To assess the diagnostic utility of surgical margin obtained through
gross examination in predicting margin negativity in patients
undergoing breast conservative surgery, with 56 as total sample size and participants have been recruited
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Women of age more than 18 years 2.Tumor stage T1, T2, T3, N0, N1 according to AJCC with no distant metastasis
- •Single clinical and mammographic lesion
- •Patients with residual disease following NACT and planned for BCS.
排除标准
- •Tumor stage T4, N2 OR M1 according to the AJCC 8th edition
- •Presence of multifocal and multicentric lesion
- •Patients with complete clinical/radiological response to chemotherapy
- •Tumor to breast tissue ratio is very high
- •Recurrent breast carcinoma
- •Women with a strong family history of carcinoma of breast or BRCA1 and BRCA2 mutation carriers.
结局指标
主要结局
To assess the diagnostic utility of surgical margin obtained through
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gross examination in predicting margin negativity in patients
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undergoing breast conservative surgery- Margin of BCS specimen will be assessed intra-op
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次要结局
- 1. Re-excision rate(2. Margin negativity at re-excision)