Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients

Koshi Kumagai, Noriko Yamamoto, Isao Miyashiro, Yasuhiko Tomita, Hitoshi Katai, Ryoji Kushima, Hitoshi Tsuda, Yuukou Kitagawa, Hiroya Takeuchi, Makio Mukai, Masayuki Mano, Hidetaka Mochizuki, Yo Kato, Nariaki Matsuura, Takeshi Sano

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Background: The accurate diagnosis of lymph node (LN) metastasis is important for making treatment decisions for gastric cancer patients. This multicenter study evaluated the clinical performance of the one-step nucleic acid amplification (OSNA) assay (Sysmex Corp.), an automated system that detects cytokeratin 19 (CK19) mRNA, in detecting LN metastases in gastric cancer patients. Methods: LNs retrieved from patients who had undergone gastric cancer surgery at one of the four Japanese hospitals involved in this study were divided into blocks at 2-mm intervals. Alternate blocks were examined with the OSNA assay and the remaining blocks were assessed histologically. Results: A total of 394 LNs from 61 patients were examined. The concordance rate between the OSNA assay and the histological examination was 0.942 (95 % CI, 0.914-0.963). Sensitivity and specificity of the OSNA assay compared to the histological examination were 0.833 (95 % CI, 0.707-0.921) and 0.959 (95 % CI, 0.932-0.977), respectively. Discordant results were observed in 23 LNs (5.8 %), and these were mainly the result of tissue allocation bias and/or low CK19 protein expression. Conclusion: The OSNA assay can detect lymph node metastases in gastric cancer patients as accurately as the histological examination of blocks sectioned at 2-mm intervals. The OSNA assay is a useful tool for the intraoperative diagnosis of LN metastasis in gastric cancer patients.

Original languageEnglish
Pages (from-to)273-280
Number of pages8
JournalGastric Cancer
Volume17
Issue number2
DOIs
Publication statusPublished - 2014

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Nucleic Acids
Multicenter Studies
Stomach Neoplasms
Lymph Nodes
Neoplasm Metastasis
Keratin-19
Decision Making
Sensitivity and Specificity
Messenger RNA
Proteins

Keywords

  • Intraoperative period
  • Keratin-19
  • Lymphatic metastasis
  • Nucleic acid amplification techniques
  • Stomach neoplasm

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research
  • Medicine(all)

Cite this

Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients. / Kumagai, Koshi; Yamamoto, Noriko; Miyashiro, Isao; Tomita, Yasuhiko; Katai, Hitoshi; Kushima, Ryoji; Tsuda, Hitoshi; Kitagawa, Yuukou; Takeuchi, Hiroya; Mukai, Makio; Mano, Masayuki; Mochizuki, Hidetaka; Kato, Yo; Matsuura, Nariaki; Sano, Takeshi.

In: Gastric Cancer, Vol. 17, No. 2, 2014, p. 273-280.

Research output: Contribution to journalArticle

Kumagai, K, Yamamoto, N, Miyashiro, I, Tomita, Y, Katai, H, Kushima, R, Tsuda, H, Kitagawa, Y, Takeuchi, H, Mukai, M, Mano, M, Mochizuki, H, Kato, Y, Matsuura, N & Sano, T 2014, 'Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients', Gastric Cancer, vol. 17, no. 2, pp. 273-280. https://doi.org/10.1007/s10120-013-0271-9
Kumagai, Koshi ; Yamamoto, Noriko ; Miyashiro, Isao ; Tomita, Yasuhiko ; Katai, Hitoshi ; Kushima, Ryoji ; Tsuda, Hitoshi ; Kitagawa, Yuukou ; Takeuchi, Hiroya ; Mukai, Makio ; Mano, Masayuki ; Mochizuki, Hidetaka ; Kato, Yo ; Matsuura, Nariaki ; Sano, Takeshi. / Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients. In: Gastric Cancer. 2014 ; Vol. 17, No. 2. pp. 273-280.
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T1 - Multicenter study evaluating the clinical performance of the OSNA assay for the molecular detection of lymph node metastases in gastric cancer patients

AU - Kumagai, Koshi

AU - Yamamoto, Noriko

AU - Miyashiro, Isao

AU - Tomita, Yasuhiko

AU - Katai, Hitoshi

AU - Kushima, Ryoji

AU - Tsuda, Hitoshi

AU - Kitagawa, Yuukou

AU - Takeuchi, Hiroya

AU - Mukai, Makio

AU - Mano, Masayuki

AU - Mochizuki, Hidetaka

AU - Kato, Yo

AU - Matsuura, Nariaki

AU - Sano, Takeshi

PY - 2014

Y1 - 2014

N2 - Background: The accurate diagnosis of lymph node (LN) metastasis is important for making treatment decisions for gastric cancer patients. This multicenter study evaluated the clinical performance of the one-step nucleic acid amplification (OSNA) assay (Sysmex Corp.), an automated system that detects cytokeratin 19 (CK19) mRNA, in detecting LN metastases in gastric cancer patients. Methods: LNs retrieved from patients who had undergone gastric cancer surgery at one of the four Japanese hospitals involved in this study were divided into blocks at 2-mm intervals. Alternate blocks were examined with the OSNA assay and the remaining blocks were assessed histologically. Results: A total of 394 LNs from 61 patients were examined. The concordance rate between the OSNA assay and the histological examination was 0.942 (95 % CI, 0.914-0.963). Sensitivity and specificity of the OSNA assay compared to the histological examination were 0.833 (95 % CI, 0.707-0.921) and 0.959 (95 % CI, 0.932-0.977), respectively. Discordant results were observed in 23 LNs (5.8 %), and these were mainly the result of tissue allocation bias and/or low CK19 protein expression. Conclusion: The OSNA assay can detect lymph node metastases in gastric cancer patients as accurately as the histological examination of blocks sectioned at 2-mm intervals. The OSNA assay is a useful tool for the intraoperative diagnosis of LN metastasis in gastric cancer patients.

AB - Background: The accurate diagnosis of lymph node (LN) metastasis is important for making treatment decisions for gastric cancer patients. This multicenter study evaluated the clinical performance of the one-step nucleic acid amplification (OSNA) assay (Sysmex Corp.), an automated system that detects cytokeratin 19 (CK19) mRNA, in detecting LN metastases in gastric cancer patients. Methods: LNs retrieved from patients who had undergone gastric cancer surgery at one of the four Japanese hospitals involved in this study were divided into blocks at 2-mm intervals. Alternate blocks were examined with the OSNA assay and the remaining blocks were assessed histologically. Results: A total of 394 LNs from 61 patients were examined. The concordance rate between the OSNA assay and the histological examination was 0.942 (95 % CI, 0.914-0.963). Sensitivity and specificity of the OSNA assay compared to the histological examination were 0.833 (95 % CI, 0.707-0.921) and 0.959 (95 % CI, 0.932-0.977), respectively. Discordant results were observed in 23 LNs (5.8 %), and these were mainly the result of tissue allocation bias and/or low CK19 protein expression. Conclusion: The OSNA assay can detect lymph node metastases in gastric cancer patients as accurately as the histological examination of blocks sectioned at 2-mm intervals. The OSNA assay is a useful tool for the intraoperative diagnosis of LN metastasis in gastric cancer patients.

KW - Intraoperative period

KW - Keratin-19

KW - Lymphatic metastasis

KW - Nucleic acid amplification techniques

KW - Stomach neoplasm

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