Management of Ductal Carcinoma in Situ (DCIS) or Pure Micro-invasive (DCIS-MI) Extended Breast, Axillary Node Sentinel Site (GAS) When the Diagnosis is Made by Biopsy and Treatment by Mastectomy Immediately. Descriptive Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ
研究概览
简要总结
When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND). The aim of this prospective multicenter trial was to determine the benefit of performing upfront sentinel lymph node (SLN) biopsy for these patients.
详细描述
The rate of axillary dissection avoided in patients with DCIS and a mastectomy indication will be obtained by calculating the proportion of women with GAS in-patient population that will prove to be DCIS or DCIS-MI + CCI (after the final histology). A confidence interval of 95% will be deferred (binomial).
The rate of axillary dissection avoided in patients with DCIS-MI and an indication of mastectomy is obtained by calculating the proportion of women with a GAS-all women with DCIS-MI and an indication of mastectomy. A confidence interval of 95% will be deferred (binomial).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years.
- •Preoperative histological diagnosis obtained by biopsy
- •Ductal carcinoma in situ (DCIS) or pure micro-invasive (DCIS-MI)
- •Indication of mastectomy
- •Patient signed informed consent
排除标准
- •Age < 18 years
- •Infiltrating ductal carcinoma (TCC) diagnosed on biopsy
- •Pure DCIS diagnosed by lumpectomy
- •DCIS can take a conservative treatment
- •Mastectomy chosen by the patient
- •History of breast carcinoma in situ or invasive ipsilateral
- •Prior radiotherapy to the ipsilateral breast
- •History of axillary lateral homo
- •Patient who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study
- •Patient deprived of liberty or under guardianship
结局指标
主要结局
Proportion of Women Who Benefited of Performing Upfront Sentinel Lymph Node (SLN) Biopsy Ductal Carcinoma in Situ
时间窗: at surgery
Women who benefited of performing upfront sentinel lymph node (SLN) biopsy are women for whom unecessary axillary lymph node dissection (ALND) was avoided. The proportion of women who benefited of performing upfront sentinel lymph node (SLN) biopsy is calculated as : * numerator : number of patients with negative SLNs * denominator : total number of patients with mastectomy-diagnosed DCIS with microinvasion (mDCIS-MI) or mastectomy-diagnosed DCIS with associated invasive carcinoma (mDCIS-IDC).
次要结局
- Discordance Rate Between Vacuum-assisted Biopsy (VAB) and Mastectomy(at surgery)