title: Diagnosis of the sentinel lymph node in breast cancer: a reproducible molecular method: a multicentric Spanish study.
abstract: OBJECTIVE
  Standardization of the sentinel node (SN) as a diagnostic tool has not yet been achieved, because the protocol for histopathological study is highly variable between centres. We compared the results of a new method with conventional histological tests and evaluated its feasibility for intra-operative evaluation, and propose it as a method to standardize the sentinel node evaluation procedure.
  
  
  RESULTS
  Trial 1 included 181 cases; in parallel, 2-mm-thick sections of the SN were processed alternately for histological analysis and for the one-step nucleic acid amplification (OSNA) procedure. A final concordance of 99.45% was observed in the first trial of our study. For trial 2, the timing of every procedural step was recorded in an electronic database in order to discern the time spent for each step, the total SN evaluation time and to identify areas of improvement. In the second trial, after a learning period and feedback on data recorded, we spent a mean of 31 min for the entire SN evaluation procedure.
  
  
  CONCLUSIONS
  Our multi-centric trial using the OSNA assay for sentinel node evaluation in breast cancer demonstrates that this is a highly sensitive, specific and reproducible technique that allows for standardization of the SN diagnostic procedure, a necessary, and until now unresolved, issue.
authors.affiliation: Department of Pathology, Hospital Lluís Alcanyís, Xátiva, Valencia, Spain. bernet_lai@gva.es
authors.forename: Laia
authors.initials: L
authors.lastname: Bernet
authors.forename: Rafael
authors.initials: R
authors.lastname: Cano
authors.forename: Marcos
authors.initials: M
authors.lastname: Martinez
authors.forename: Basilio
authors.initials: B
authors.lastname: Dueñas
authors.forename: Xavier
authors.initials: X
authors.lastname: Matias-Guiu
authors.forename: Lluisa
authors.initials: L
authors.lastname: Morell
authors.forename: Jose
authors.initials: J
authors.lastname: Palacios
authors.forename: Ricardo
authors.initials: R
authors.lastname: Rezola
authors.forename: Maria
authors.initials: M
authors.lastname: Robles-Frias
authors.forename: Irune
authors.initials: I
authors.lastname: Ruiz
authors.forename: Ana
authors.initials: A
authors.lastname: Velasco
authors.forename: Begoña
authors.initials: B
authors.lastname: Vieites
authors.forename: Francisco
authors.initials: F
authors.lastname: Sevilla
authors.forename: Jose
authors.initials: J
authors.lastname: Torro
authors.forename: Jose
authors.initials: J
authors.lastname: Medrano
authors.forename: Blai
authors.initials: B
authors.lastname: Ballester
mesh_terms: D001943:Breast Neoplasms / Q000473:pathology*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000473:pathology; D004273:DNA, Neoplasm / Q000235:genetics*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis / Q000175:diagnosis* / Q000235:genetics*; D016343:Monitoring, Intraoperative / Q000379:methods; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D013030:Spain; D013997:Time Factors
chemical_list: D004273:DNA, Neoplasm