title: [Evaluation of intraoperative molecular assay in sentinel lymph node biopsy from breast cancer patients].
abstract: OBJECTIVE
  to evaluate the application of GeneSearch(TM) breast lymph node assay in intraoperative detection of metastases in sentinel lymph node (SLN) from breast cancer patients.
  
  
  METHODS
  a total of 225 SLN from 88 patients was prospectively studied. Each SLN was cut into 2 mm slabs which were examined by intraoperative imprint cytology (IIC) first, followed by GeneSearch assay and post-operative serial sectioning. GeneSearch used real-time fluorescence quantitative RT-PCR technology to detect the expression of CK19 and mammaglobin in SLN. The results of GeneSearch assay were correlated with those of IIC and post-operative serial sectioning.
  
  
  RESULTS
  amongst the 88 cases studied, 225 SLNs were found, and obvious metastatic carcinoma cells were identified in 27 SLNs and micrometastasis in 9 SLNs. One hundred and eight-nine SLNs were considered as "negative" (with "isolated tumor cells" present in 5 SLNs). The turn-around time of intraoperative GeneSearch assay ranged from 35 to 45 minutes (mean = 40 minutes). The concordance rate between GeneSearch assay and post-operative serial sectioning was 95.6% (215/225), with a sensitivity of 86.1% (31/36), compared with 94.7% (213/225) and 72.2% (26/36) respectively for IIC. The size of metastatic foci correlated with the Ct value of CK19 and mammaglobin (P < 0.01).
  
  
  CONCLUSIONS
  GeneSearch assay for intraoperative detection of metastase in SLN has a satisfactory performance and demonstrates a relatively higher sensitivity than IIC. The potential clinical application still requires further evaluation of larger number of cases.
authors.affiliation: Department of Pathology, Cancer Hospital, Fudan University and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.
authors.forename: Da-Li
authors.initials: DL
authors.lastname: Li
authors.forename: Wen-Tao
authors.initials: WT
authors.lastname: Yang
authors.forename: Xu
authors.initials: X
authors.lastname: Cai
authors.forename: Xiao-Li
authors.initials: XL
authors.lastname: Xu
authors.forename: Wei-Ping
authors.initials: WP
authors.lastname: Xu
authors.forename: Jia-Jian
authors.initials: JJ
authors.lastname: Chen
authors.forename: Ben-Long
authors.initials: BL
authors.lastname: Yang
authors.forename: Jiong
authors.initials: J
authors.lastname: Wu
authors.forename: Da-Ren
authors.initials: DR
authors.lastname: Shi
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D018567:Breast Neoplasms, Male / Q000378:metabolism / Q000473:pathology / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D007432:Intraoperative Period; D053539:Keratin-19 / Q000378:metabolism; D008198:Lymph Nodes / Q000378:metabolism / Q000473:pathology* / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D060785:Mammaglobin A; D008408:Mastectomy / Q000379:methods; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000378:metabolism; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D014598:Uteroglobin / Q000378:metabolism
chemical_list: D053539:Keratin-19; D060785:Mammaglobin A; D009363:Neoplasm Proteins; C556448:SCGB2A2 protein, human; D014598:Uteroglobin