title: OSNA-Assisted Molecular Staging in Colorectal Cancer: A Prospective Multicenter Trial in Japan.
abstract: BACKGROUND
  We previously reported that the one-step nucleic acid amplification (OSNA) assay provided a judgment performance for colorectal cancer equivalent to a 2-mm-interval histopathological examination of lymph nodes (concordance 97.1 %, n = 385 lymph nodes). In this prospective multicenter study, we uncovered an OSNA-assisted pathology to detect lymph node metastasis.
  
  
  METHODS
  A total of 204 (50 stage I, 74 stage II, and 80 stage III) colorectal cancer patients. All 4324 lymph nodes were examined by the standard histology (one-slice H&E staining) and 1925 lymph nodes (44.5 %) of them were also subject to the OSNA analysis.
  
  
  RESULTS
  The concordance rate between 1 slice hematoxylin/eosin and OSNA assay was 95.7 % (1,842/1925 lymph nodes). The sensitivity and specificity of the OSNA assay were 86.2 % (125/145) and 96.5 % (1717/1780), respectively. Among 124 node-negative patients (pN0), the respective upstaging rates of pStages I, IIA, IIB, and IIC were 2.0 % (1/50), 17.7 % (11/62), 12.5 % (1/8), and 25 % (1/4). OSNA-positive patients had deeper invasion to the colonic wall and severe lymphatic invasion (P = 0.048 and P = 0.004, respectively). The sum of the quantitative results of OSNA and total tumor load increased as the number of metastasized lymph nodes increased: 1550 copies/μL in pN0, 24,050 copies/μL in pN1, and 90,600 copies/μL in pN2.
  
  
  CONCLUSIONS
  The present study on colorectal cancer provided fundamental data regarding OSNA-assisted pathology of lymph node metastasis in Japan.
authors.affiliation: Division of Health Sciences, Department of Molecular Pathology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan. hyamamoto@gesurg.med.osaka-u.ac.jp.|Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan. hyamamoto@gesurg.med.osaka-u.ac.jp.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yamamoto
authors.affiliation: Department of Surgery, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Tomita
authors.affiliation: Department of Gastroenterological and Pediatric Surgery, Faculty of Medicine, Oita University, Yufu, Oita, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Inomata
authors.affiliation: Department of Nursing School of Health Sciences, Sapporo Medical University, Sapporo, Hokkaido, Japan.
authors.forename: Tomohisa
authors.initials: T
authors.lastname: Furuhata
authors.affiliation: Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Hyogo, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyake
authors.affiliation: Department of Surgery, Osaka Rosai Hospital, Sakai, Osaka, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Noura
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kato
authors.affiliation: Department of Surgery, Suita Municipal Hospital, Suita, Osaka, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Murata
authors.affiliation: Department of Digestive Surgery, Surugadai Nihon University Hospital, Chiyoda-ku, Tokyo, Japan.
authors.forename: Shigeoki
authors.initials: S
authors.lastname: Hayashi
authors.affiliation: Division of Pathology, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Igarashi
authors.affiliation: Department of Surgery II, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan.
authors.forename: Michio
authors.initials: M
authors.lastname: Itabashi
authors.affiliation: Department of Surgery II, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kameoka
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Osaka, Japan.
authors.forename: Nariaki
authors.initials: N
authors.lastname: Matsuura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000032:analysis*; D015179:Colorectal Neoplasms / Q000235:genetics / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D053539:Keratin-19 / Q000235:genetics*; D008198:Lymph Nodes / Q000378:metabolism / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D011379:Prognosis; D011446:Prospective Studies
chemical_list: D014408:Biomarkers, Tumor; D053539:Keratin-19