Evidence map›Paper›PMID 31062258›Full record

ArticleMedical oncology (Northwood, London, England)2019

Performance of a new system using a one-step nucleic acid amplification assay for detecting lymph node metastases in breast cancer.

Kenzo Shimazu, Tomonori Tanei, Yasuhiro Tamaki, Toshiaki Saeki, Akihiko Osaki, Takahiro Hasebe, Yasuhiko Tomita, Motonari Daito, Mayuko Kobayashi, Shinzaburo Noguchi

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In one paragraph

Article in Medical oncology (Northwood, London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Kenzo ShimazuDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2-E10 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan. kshimazu@onsurg.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0002-0837-2357
Tomonori TaneiDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2-E10 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan.
Yasuhiro TamakiDepartment of Breast and Endocrine Surgery, Osaka International Cancer Institute, Osaka, Japan.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Akihiko OsakiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Takahiro HasebeDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Yasuhiko TomitaDepartment of Pathology, International University of Health and Welfare, Chiba, Japan.
Motonari DaitoGene Testing Business, Sysmex Corporation, Kobe, Japan.
Mayuko KobayashiGene Testing Business, Sysmex Corporation, Kobe, Japan.
Shinzaburo NoguchiDepartment of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-2-E10 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan.
Saitama Medical University · JPThe University of Osaka · JPSysmex (Japan) · JPInternational University of Health and Welfare · JPOsaka International Cancer Institute · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

One-step nucleic acid amplification (OSNA) for CK19 mRNA is an intraoperative diagnostic procedure for detection of lymph node metastasis. Automated Gene Amplification Detector RD-200 and the LYNOAMP CK19 gene amplification reagent as components of a new OSNA system have been developed. As an improvement over a conventional system, the new system can analyze 14 samples per run, evaluate two lymph nodes in ~ 17 min, and reduce inhibition of reactions. This study was aimed at evaluating clinical performance of the new system by comparing it with performance of histopathological analysis and a conventional OSNA system. A total of 150 lymph nodes in 63 breast cancer patients (T1-3) who underwent sentinel lymph node biopsy or axillary lymph node dissection were examined intraoperatively with the new OSNA system, the conventional system, and histopathological analysis. In comparison with histopathological analysis, sensitivity, specificity, and concordance rate of the new system were 93.9, 98.8, and 96.7%, respectively. In comparison with the conventional system, similar corresponding values were obtained: 96.9, 98.8, and 98.0%, respectively. The results show that clinical performance of the new OSNA system is equivalent to that of histopathological diagnosis and the conventional OSNA system. The new system is superior to the conventional one because of processing of a greater number of samples, shorter testing time, and the absence of inhibited reactions.

Indexed as

AdultAgedAged, 80 and overAxillaBiomarkers, TumorBreast NeoplasmsFemaleHumansIntraoperative PeriodKeratin-19Lymphatic MetastasisLymph NodesMiddle AgedNucleic Acid Amplification TechniquesRNA, MessengerSensitivity and SpecificityBiomarkers, TumorKeratin-19KRT19 protein, humanRNA, MessengerAxillary lymph node metastasisBreast cancerCK19 mRNAOne-step nucleic acid amplification assay

Identifiers

PMID31062258
OpenAlexW2944618188

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.