Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 701
- 试验地点
- 9
- 主要终点
- Estimate the negative predictive value of the technique OSNA.
研究概览
简要总结
This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed invasive breast carcinoma
- •Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices
- •Intraoperative evaluation of sentinel lymph node (SLN) by OSNA
- •Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA
- •Pathology report of the tumor and dissected lymph nodes that includes the following information:
- •primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor status
- •progesterone receptor status
- •HER2 status (ASCO/CAP guidelines)
- •Ki67 index
- •presence/absence of lymphovascular invasion
- •total number of sentinel and non-sentinel lymph nodes dissected during surgery
- •total number of positive and negative sentinel and non-sentinel lymph nodes, *size of the metastasis in both sentinel and non-sentinel lymph nodes
- •total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA copies per microliter.
排除标准
- •Patients who underwent neoadjuvant chemotherapy
- •CK19-negative breast tumor
- •ALND with <10 lymph nodes
- •In situ carcinoma only
- •Metastatic breast cancer at time of diagnosis
结局指标
主要结局
Estimate the negative predictive value of the technique OSNA.
时间窗: At time of surgery
Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.
次要结局
- ROC curve that describes the assay(At time of surgery)
- Sensitivity of the assay(At time of surgery)
- Specificity of the assay(At time of surgery)
- Likelihood ratio for the cutoff of 10,000-15,000 copies/uL(At time of surgery)
- Positive predictive value at the cutoff of 10.000-15.000 copies/μL.(At time of surgery)