Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSNA<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the negative predictive value of the technique OSNA. | 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. | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC curve that describes the assay | ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs | At time of surgery | 
| Sensitivity of the assay | Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN) | At time of surgery | 
| Specificity of the assay | Probability that OSNA in SLN is negative because there is no involvement of NSLN | At time of surgery | 
| Likelihood ratio for the cutoff of 10,000-15,000 copies/uL | Likelihood ratio of positive and negative results | At time of surgery | 
| Positive predictive value at the cutoff of 10.000-15.000 copies/μL. |  | At time of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, OSNA, sentinel lymph node