Histological and cytological evaluation of subnipple biopsy in predicting neoplasic involvement of the nipple in patients with breast carcinoma

Abstract

The objective of the study is evaluate the accuracy of subnipple biopsy (SNB) in predicting nipple commitment in women with breast carcinoma. We will develop a diagnostic test study with 65 patients that are going underwent total mastectomy or central quadrantectomy in CAISM / UNICAMP. After the proposed surgery, the nipple areolar complex (NAC) will be dissected in approximate 5 mm thickness simulating the dissection flap nipple-sparing type. Then, a sample of subnipple tissue will be obtained. We will do an imprint of SNB to cytologic analyses and subsequently histopathological evaluation (by frozen and paraffin seccion). The nipple and SNB will be evaluated separately from the mastectomy specimen by the pathologist. Histopathological findings of the two specimens are going to compare and determine the accuracy of the SNB to predict nipple neoplasia. The presence of tumor in nipple and SNB will be analyzed by considering the following control variables: age, menopausal status, tumor size and location of the breast tumor, distance from the NAC, the presence of extensive intraductal component, histologic type of and evaluation of tumor hormone receptors, HER-2 and Ki-67. Quantitative variables will be analyzed using Student t test and qualitative variables using the chi-square. It will be calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy as well as their confidence intervals of SNB (cytology and histology) considering the nipple histology as the gold standard. The analysis will be carried out with SAS 9.2 and be given a significance level of 5%. (AU)