TY - JOUR
T1 - Detection of sentinel lymph node metastases in cervical cancer
T2 - Assessment of KRT19 mRNA in the one-step nucleic acid amplification (OSNA) method
AU - Okamoto, Satoshi
AU - Niikura, Hitoshi
AU - Nakabayashi, Kadzuki
AU - Hiyama, Kayo
AU - Matoda, Maki
AU - Takeshima, Nobuhiro
AU - Watanabe, Mika
AU - Nagase, Satoru
AU - Otsuki, Takeo
AU - Yaegashi, Nobuo
N1 - Funding Information:
The authors would like to thank Ms. Emi Endo and Ms. Aya Miyabe for their substantial support. This study was supported in part by a Grant-in-Aid for Scientific Research on Priority Areas from the Ministry of Education, Science and Culture, Japan ; a Grant-in-Aid for Scientific Research (B) and (C); a Grant-in-Aid for Young Scientists (B); a Grant-in-Aid for Exploratory Research, from the Ministry of Education, Science, Sports and Culture, Japan ; a Grant-in-Aid from the Ministry of Health, Labor and Welfare, Japan ; the 21st Century COE Program Special Research Grant (Tohoku University) from the Ministry of Education Science, Sports and Culture, Japan; and the Uehara Memorial Foundation .
PY - 2013/9
Y1 - 2013/9
N2 - Objective The purpose of this study was to examine the utility of the one-step nucleic acid amplification (OSNA) assay using cytokeratin (CK) 19 (KRT19) messenger RNA (mRNA) for the detection of sentinel lymph node (SLN) metastases in cervical cancer patients. Methods To determine a cutoff value, KRT19 mRNA was assessed by OSNA assay using 239 lymph nodes (LNs) (217 histopathologically negative LNs and 22 positive LNs). A cutoff value was determined by statistical analysis of the copy numbers obtained by OSNA assay. Subsequently, performance evaluation of the OSNA assay (applying the cutoff value above) on 130 SLNs (32 patients) was used to investigate (through concordance) whether the OSNA assay exhibited diagnostic performance equivalent to the two-mm interval histopathological examination. Results Two hundred fifty copies/μL of KRT19 mRNA in the OSNA assay appeared to be an optimal cutoff value. In performance evaluation of the OSNA assay, we identified five positive SLNs and 125 negative SLNs by OSNA assay using KRT19 mRNA, exhibiting 96.2% agreement with two-mm interval histopathological examination. Conclusions Our results indicated that the KRT19 mRNA OSNA assay can detect LN metastases as accurately as two-mm interval histopathological examination and thus may be an effective additional or alternative method for a rapid intra-operative examination of SLNs in cervical cancer.
AB - Objective The purpose of this study was to examine the utility of the one-step nucleic acid amplification (OSNA) assay using cytokeratin (CK) 19 (KRT19) messenger RNA (mRNA) for the detection of sentinel lymph node (SLN) metastases in cervical cancer patients. Methods To determine a cutoff value, KRT19 mRNA was assessed by OSNA assay using 239 lymph nodes (LNs) (217 histopathologically negative LNs and 22 positive LNs). A cutoff value was determined by statistical analysis of the copy numbers obtained by OSNA assay. Subsequently, performance evaluation of the OSNA assay (applying the cutoff value above) on 130 SLNs (32 patients) was used to investigate (through concordance) whether the OSNA assay exhibited diagnostic performance equivalent to the two-mm interval histopathological examination. Results Two hundred fifty copies/μL of KRT19 mRNA in the OSNA assay appeared to be an optimal cutoff value. In performance evaluation of the OSNA assay, we identified five positive SLNs and 125 negative SLNs by OSNA assay using KRT19 mRNA, exhibiting 96.2% agreement with two-mm interval histopathological examination. Conclusions Our results indicated that the KRT19 mRNA OSNA assay can detect LN metastases as accurately as two-mm interval histopathological examination and thus may be an effective additional or alternative method for a rapid intra-operative examination of SLNs in cervical cancer.
KW - Cervical cancer
KW - Cytokeratin 19
KW - Micrometastasis
KW - One-step nucleic acid amplification (OSNA)
KW - Sentinel lymph node (SLN)
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U2 - 10.1016/j.ygyno.2013.06.027
DO - 10.1016/j.ygyno.2013.06.027
M3 - Article
C2 - 23811115
AN - SCOPUS:84882452892
VL - 130
SP - 530
EP - 536
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 3
ER -