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.
Study Type
OBSERVATIONAL
Enrollment
701
Hospital Clínico Universitario de Santiago de Compostela
A Coruña, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Vall d´Hebron University Hospital
Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas, Spain
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.
Time frame: At time of surgery
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
Time frame: 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)
Time frame: At time of surgery
Specificity of the assay
Probability that OSNA in SLN is negative because there is no involvement of NSLN
Time frame: At time of surgery
Likelihood ratio for the cutoff of 10,000-15,000 copies/uL
Likelihood ratio of positive and negative results
Time frame: At time of surgery
Positive predictive value at the cutoff of 10.000-15.000 copies/μL.
Time frame: At time of surgery
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