caa a22 4500 445334169 CHVBK 20180317142747.0 cr unu---uuuuu 170323e20110701xx s 000 0 eng 10.1245/s10434-010-1539-5 doi (NATIONALLICENCE)springer-10.1245/s10434-010-1539-5 OSNA-Based Novel Molecular Testing for Lymph Node Metastases in Colorectal Cancer Patients: Results from a Multicenter Clinical Performance Study in Japan [Elektronische Daten] [Hirofumi Yamamoto, Mitsugu Sekimoto, Masatoshi Oya, Noriko Yamamoto, Fumio Konishi, Junichi Sasaki, Shigeki Yamada, Kiyomi Taniyama, Harumi Tominaga, Masahiko Tsujimoto, Hiroki Akamatsu, Akio Yanagisawa, Chouhei Sakakura, Yo Kato, Nariaki Matsuura] Background: Lymph node (LN) metastasis in colorectal cancer (CRC) is a critical factor in making accurate prognoses and therapeutic decisions. This study evaluated the clinical performance of the one-step nucleic acid amplification (OSNA) assay in accurately diagnosing LN metastases in CRC patients through the specific detection of cytokeratin 19 mRNA levels in LNs. Methods: The OSNA assay was performed on 121 LNs dissected from early-stage CRC patients (pStage 0 or I) or from patients with benign colorectal disease (study 1). Separately, 385 LNs were dissected from 85 CRC patients (any stage); the OSNA assay was performed on half of each LN, and the results were compared with histopathological examination in 2-mm intervals of the other LN half (study 2). Results: In study 1, all 121 histopathologically negative LNs were also negative by the OSNA assay (concordance rate for metastasis negative: 1.0, 95% confidence interval [95% CI]: 0.976-1.0). In study 2, the concordance rate between the OSNA assay and the 2-mm-interval histopathological examination was 0.971 (95% CI: 0.950-0.984), with a sensitivity of 0.952 (95% CI: 0.881-0.987) and a specificity of 0.977 (95% CI: 0.953-0.991). Conclusions: The OSNA assay provided a judgment performance equivalent to a 2-mm-interval histopathological examination, a more detailed assay than the common pathological examination. Therefore, the OSNA assay is considered a new molecular examination method for the diagnosis of LN metastases in CRC patients in clinical settings. Society of Surgical Oncology, 2011 Yamamoto Hirofumi Department of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan aut Sekimoto Mitsugu Department of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan aut Oya Masatoshi Gastroenterological Center, Department of Gastroenterological Surgery, Cancer Institute Ariake Hospital, Tokyo, Japan aut Yamamoto Noriko Department of Pathology, The Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan aut Konishi Fumio Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan aut Sasaki Junichi Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan aut Yamada Shigeki Department of Pathology, Saitama Medical Center, Jichi Medical University, Saitama, Japan aut Taniyama Kiyomi Institute for Clinical Research, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Hiroshima, Japan aut Tominaga Harumi Department of Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Hiroshima, Japan aut Tsujimoto Masahiko Department of Pathology, Osaka Police Hospital, Osaka, Japan aut Akamatsu Hiroki Department of Surgery, Osaka Police Hospital, Osaka, Japan aut Yanagisawa Akio Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan aut Sakakura Chouhei Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan aut Kato Yo Department of Pathology, The Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan aut Matsuura Nariaki Department of Molecular Pathology, Graduate School of Medicine and Health Science, Osaka University, Osaka, Japan aut Annals of Surgical Oncology Springer-Verlag 18/7(2011-07-01), 1891-1898 1068-9265 18:7<1891 2011 18 10434 https://doi.org/10.1245/s10434-010-1539-5 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1245/s10434-010-1539-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Yamamoto Hirofumi Department of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan aut NATIONALLICENCE 700 1- Sekimoto Mitsugu Department of Surgery, Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan aut NATIONALLICENCE 700 1- Oya Masatoshi Gastroenterological Center, Department of Gastroenterological Surgery, Cancer Institute Ariake Hospital, Tokyo, Japan aut NATIONALLICENCE 700 1- Yamamoto Noriko Department of Pathology, The Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan aut NATIONALLICENCE 700 1- Konishi Fumio Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan aut NATIONALLICENCE 700 1- Sasaki Junichi Department of Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan aut NATIONALLICENCE 700 1- Yamada Shigeki Department of Pathology, Saitama Medical Center, Jichi Medical University, Saitama, Japan aut NATIONALLICENCE 700 1- Taniyama Kiyomi Institute for Clinical Research, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Hiroshima, Japan aut NATIONALLICENCE 700 1- Tominaga Harumi Department of Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Hiroshima, Japan aut NATIONALLICENCE 700 1- Tsujimoto Masahiko Department of Pathology, Osaka Police Hospital, Osaka, Japan aut NATIONALLICENCE 700 1- Akamatsu Hiroki Department of Surgery, Osaka Police Hospital, Osaka, Japan aut NATIONALLICENCE 700 1- Yanagisawa Akio Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan aut NATIONALLICENCE 700 1- Sakakura Chouhei Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan aut NATIONALLICENCE 700 1- Kato Yo Department of Pathology, The Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan aut NATIONALLICENCE 700 1- Matsuura Nariaki Department of Molecular Pathology, Graduate School of Medicine and Health Science, Osaka University, Osaka, Japan aut NATIONALLICENCE 773 0- Annals of Surgical Oncology Springer-Verlag 18/7(2011-07-01), 1891-1898 1068-9265 18:7<1891 2011 18 10434 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer