Evidence map›Paper›PMID 41068661›Full record

ArticleBMC cancer2025

Prospective multicenter validation of a next-generation sequencing panel using cytology specimens for lung cancer: cPANEL.

Kei Morikawa, Yuta Takashima, Masahide Oki, Akifumi Tsuzuku, Shuji Murakami, Daisuke Minami, Shinji Fujii, Naofumi Shinagawa, Fumihiro Asano, Seiji Nakamura and 6 more

Abstract readMulticenter StudyValidation Study
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
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

16 authors.

Kei MorikawaDepartment of Respiratory Medicine, St. Marianna University School of Medicine, Kawasaki, Japan. mokke@marianna-u.ac.jp.
Yuta TakashimaDepartment of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Masahide OkiDepartment of Respiratory Medicine, NHO Nagoya Medical Center, Nagoya, Japan.
Akifumi TsuzukuDepartment of Respiratory Medicine, Gifu Prefectural General Medical Center, Gifu, Japan.
Shuji MurakamiDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Daisuke MinamiDepartment of Respiratory Medicine, Kawasaki Medical School, Kurashiki, Japan.
Shinji FujiiDepartment of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan.
Naofumi ShinagawaDepartment of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Fumihiro AsanoDepartment of Respiratory Medicine, Gifu Prefectural General Medical Center, Gifu, Japan.
Seiji NakamuraDNA Chip Research, Inc, Kawasaki, Japan.
Yoshiharu SatoDNA Chip Research, Inc, Kawasaki, Japan.
Yumi UedaDNA Chip Research, Inc, Kawasaki, Japan.
Fumihiko SuzukiDNA Chip Research, Inc, Kawasaki, Japan.
Tomoyuki YokoseDepartment of Pathology, Kanagawa Cancer Center, Yokohama, Japan.
Kenichiro TanabePathology and Bioregulation, St. Marianna University Graduate School of Medicine, Kawasaki, Japan.
Masamichi MineshitaDepartment of Respiratory Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are no prospective studies to estimate whether cytology specimens can replace tissue samples using lung cancer gene panel analysis. We evaluated the success rate of gene panel testing and nucleic acid yield and quality when using cytology specimens for lung cancer over tissue specimens.

methodsIn this prospective study, clinical cytology specimens collected via transbronchial brushing, needle aspiration washing, and pleural effusion were stored in a nucleic acid stabilizer. The primary endpoint was the superior success rate of gene analysis using cytology specimens over the conventional success rate using tissue specimens.

resultsThe full analysis set included 248 cases. The success rate for gene panel analysis using cytology specimens was 98.4% (95% confidence interval (CI), 95.9-99.6%) with a positive concordance rate of 97.3% (95% CI, 90.7-99.7%) by other companion diagnostic kits. The median value for nucleic acid yield and quality (DNA/RNA integrated number) of cytology specimens was 546.0/426.5 ng and 9.2/4.7 for DNA/RNA, respectively. The Pearson correlation coefficient of variant allele frequency between tissue formalin-fixed and paraffin-embedded (FFPE) sample and cytology specimens for mutant cases was 0.815. The ratio of double-stranded to total DNA showed that cytology specimens were of significantly higher quality than FFPE specimens.

conclusionsThe success rate of cytology specimens in gene analysis was significantly higher than conventional data. Because of the sufficient nucleic acid yield, high quality, and high correlation of mutant allele frequency compared to FFPE specimens, cytology specimens are suitable for panel testing as tissue substitutes.

trial registrationUMIN Registry UMIN000047215 (cPANEL trial).  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053766 .

Indexed as

High-Throughput Nucleotide SequencingLung NeoplasmsAdultAgedAged, 80 and overCytodiagnosisFemaleHumansMaleMiddle AgedProspective StudiesCytology specimenGene panel analysisNext-generation sequencingNon-small cell carcinomaVariant allele frequency

Identifiers

PMID41068661
PMCPMC12512683

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Registered trials

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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.