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; Yuko Kitagawa; Hiroya Takeuchi; Makio Mukai; Masayuki Mano; Hidetaka Mochizuki; Yo Kato; Nariaki Matsuura; Takeshi Sano

doi:10.1007/s10120-013-0271-9

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, Yuko Kitagawa, Hiroya Takeuchi, Makio Mukai, Masayuki Mano, Hidetaka Mochizuki, Yo Kato, Nariaki Matsuura, Takeshi Sano

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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 language	English
Pages (from-to)	273-280
Number of pages	8
Journal	Gastric Cancer
Volume	17
Issue number	2
DOIs	https://doi.org/10.1007/s10120-013-0271-9
Publication status	Published - 2014 Apr

Keywords

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

ASJC Scopus subject areas

Oncology
Gastroenterology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s10120-013-0271-9

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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, 17(2), 273-280. https://doi.org/10.1007/s10120-013-0271-9

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

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

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.",

keywords = "Intraoperative period, Keratin-19, Lymphatic metastasis, Nucleic acid amplification techniques, Stomach neoplasm",

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

note = "Funding Information: We thank Mr. K. Nakabayashi and Mr. D. Kobayashi from Sysmex Corp. Mr. Nakabayashi made an enormous contribution to the current study in RT-PCR. Mr. Kobayashi has been tolerant and supportive in monitoring four hospitals. The study was supported by Sysmex Corporation. The costs of publication of this article were defrayed in part by the payment of page charges. This article must, therefore, be hereby marked advertisement in accordance with 18 USC Section 1734 solely to indicate this fact. ",

year = "2014",

month = apr,

doi = "10.1007/s10120-013-0271-9",

language = "English",

volume = "17",

pages = "273--280",

journal = "Gastric Cancer",

issn = "1436-3291",

publisher = "Springer Japan",

number = "2",

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TY - JOUR

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, Yuko

AU - Takeuchi, Hiroya

AU - Mukai, Makio

AU - Mano, Masayuki

AU - Mochizuki, Hidetaka

AU - Kato, Yo

AU - Matsuura, Nariaki

AU - Sano, Takeshi

N1 - Funding Information: We thank Mr. K. Nakabayashi and Mr. D. Kobayashi from Sysmex Corp. Mr. Nakabayashi made an enormous contribution to the current study in RT-PCR. Mr. Kobayashi has been tolerant and supportive in monitoring four hospitals. The study was supported by Sysmex Corporation. The costs of publication of this article were defrayed in part by the payment of page charges. This article must, therefore, be hereby marked advertisement in accordance with 18 USC Section 1734 solely to indicate this fact.

PY - 2014/4

Y1 - 2014/4

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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SN - 1436-3291

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JO - Gastric Cancer

JF - Gastric Cancer

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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