title: Intraoperative molecular assessment for lymph node metastasis in head and neck squamous cell carcinoma using one-step nucleic acid amplification (OSNA) assay.
abstract: BACKGROUND
  Conventional intraoperative pathological examination for Sentinel node navigation surgery (SNNS) has been controversial. We evaluated the efficacy of one-step nucleic acid amplification (OSNA) assay for intraoperative diagnosis of cervical lymph node (CLN) metastasis compared with histopathological examination in patients with head and neck squamous cell carcinoma (HNSCC).
  
  
  METHODS
  A total of 175 CLNs dissected from 56 patients with HNSCC who underwent surgery at Aichi Cancer Center, Kyorin University, Gunma University or Fukushima Medical University, between April 2008 and December 2011 were enrolled. CLN samples were sectioned into four equal pieces, with two of each used for OSNA assay and other histopathological examinations. The diagnostic value of OSNA assay in HNSCC patients in predicting the results of histopathological diagnosis was evaluated using the area under the receiver operating characteristic (AUROC) curve.
  
  
  RESULTS
  OSNA assay showed acceptable efficacy in the detection of pathological CLN metastasis (AUROC 0.918, 95 % confidence interval [CI] 0.852-0.984). Regarding the CK19mRNA cutoff value, the optimum cutoff point in HNSCC patients was 131 copies/μl (sensitivity: 82.4, 95 % CI 65.5-93.2; specificity: 99.3, 95 % CI 96.1-100.0; positive likelihood ratio 116.1; negative likelihood ratio 0.2].
  
  
  CONCLUSIONS
  We demonstrated that OSNA assay is useful in intraoperative diagnosis for CLN metastasis in patients with HNSCC. OSNA assay could be applied for SNNS in HNSCC patients.
authors.affiliation: Department of Otolaryngology, Fukushima Medical University School of Medicine, Fukushima, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Matsuzuka
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Takahashi
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kawakita
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Kohno
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nagafuji
authors.forename: Koichi
authors.initials: K
authors.lastname: Yamauchi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Suzuki
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Miura
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Furuya
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Yatabe
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsuo
authors.forename: Koichi
authors.initials: K
authors.lastname: Omori
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Hasegawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000235:genetics*; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000235:genetics / Q000601:surgery; D004273:DNA, Neoplasm / Q000235:genetics*; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000601:surgery; D006801:Humans; D007432:Intraoperative Period; D053539:Keratin-19 / Q000235:genetics*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D009367:Neoplasm Staging; D021141:Nucleic Acid Amplification Techniques; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors
chemical_list: D014408:Biomarkers, Tumor; D004273:DNA, Neoplasm; D053539:Keratin-19