A Clinical Trial to Verify the Efficiency of the LC-1000 Exfoliative Cell Analyzer as a New Method of Cervical Cancer Screening

Masaru Nakamura, Masatugu Ueda, Takashi Iwata, Kazushige Kiguchi, Yoshiki Mikami, Tatsuyuki Kakuma, Daisuke Aoki

Research output: Contribution to journalArticle

Abstract

Objective: The exfoliative cell analyzer, LC-1000 (Sysmex Corporation, Japan), is a medical device that presents the cell proliferation index and 23 research parameters as indicators of cellular proliferative potential. The objective was to evaluate the clinical usability of qualitative assessment by LC-1000 compared with cytology, the human papillomavirus (HPV) test, and histology as gold standard. Study Design: Women that visited 3 sites between July 2015 and March 2017 were registered. The primary endpoint in this study was the comparison between LC-1000 measurement and HPV test for sensitivity and specificity for cervical intraepithelial neoplasia 2+ (CIN2+). A tree model algorithm was newly constructed by a statistical method and its relationship with histological results was evaluated. Results: The sensitivity and specificity of LC-1000 were 78.3 and 74.1%, while those of the HPV test were 94.7 and 85.4%, respectively. A tree model comprising five categories was constructed. The proportion of advanced lesions was higher with the change in the rank classification results from 1 to 5. The positive predictive values of CIN2+ in the categories 4 and 5 were high. Despite the small number of subjects, cancer was undetected in categories 1 and 2. In addition, the comparison with follow-up results in 19 women assessed as CIN1 showed that the rate of progression in the categories 3-5 was 50% (7/14); progression in the categories 1 and 2 was 0% (0/5). Conclusions: LC-1000 may be useful for cervical cancer screening as an index to qualitatively evaluate CIN and cancer based on the changes in characteristics of cells.

Original languageEnglish
JournalActa Cytologica
DOIs
Publication statusPublished - 2019 Jan 1

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Early Detection of Cancer
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Clinical Trials
Sensitivity and Specificity
Cell Biology
Neoplasms
Histology
Japan
Cell Proliferation
Equipment and Supplies
Research

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Histology

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A Clinical Trial to Verify the Efficiency of the LC-1000 Exfoliative Cell Analyzer as a New Method of Cervical Cancer Screening. / Nakamura, Masaru; Ueda, Masatugu; Iwata, Takashi; Kiguchi, Kazushige; Mikami, Yoshiki; Kakuma, Tatsuyuki; Aoki, Daisuke.

In: Acta Cytologica, 01.01.2019.

Research output: Contribution to journalArticle

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