Evidence map›Paper›PMID 30443013›Full record

ArticleModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2019

Keratin 17 is a sensitive and specific biomarker of urothelial neoplasia.

Sruthi Babu, Daniel C Mockler, Lucia Roa-Peña, Agnieszka Szygalowicz, Nam W Kim, Sholeh Jahanfard, Shahram S Gholami, Richard Moffitt, John P Fitzgerald, Luisa F Escobar-Hoyos and 1 more

Open access · bronzeAbstract readValidation Study
PubMed Publisher
In one paragraph

Article in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.0field-weighted citation impact, top 4% 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

30 citing papers in PubMed, 54 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Clinical Experience with URO17Journal of clinical medicine · 2025
    Article
  5. Article
  6. Bladder cancer biomarkers.Exploration of targeted anti-tumor therapy · 2025
    Review
  7. Advances in Liquid Biopsy for Diagnosis of Bladder Cancer.International neurourology journal · 2024
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. The Role of Keratin17 in Human Tumours.Frontiers in cell and developmental biology · 2022
    Review
  19. Article
  20. 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

11 authors at 2 institutions in 2 countries.

Sruthi BabuDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA.ORCID http://orcid.org/0000-0002-5214-7229
Daniel C MocklerDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA.
Lucia Roa-PeñaDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA.ORCID http://orcid.org/0000-0002-3037-4906
Agnieszka SzygalowiczDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA.ORCID http://orcid.org/0000-0003-4328-0316
Nam W KimKDx Diagnostics Inc, Campbell, CA, USA.
Sholeh JahanfardKDx Diagnostics Inc, Campbell, CA, USA.
Shahram S GholamiKDx Diagnostics Inc, Campbell, CA, USA.
Richard MoffittDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA.
John P FitzgeraldDepartment of Urology, Stony Brook Medicine, Stony Brook, NY, USA.
Luisa F Escobar-HoyosDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA. luisa.escobarhoyos@stonybrookmedicine.edu.
Kenneth R ShroyerDepartment of Pathology, Stony Brook Medicine, Stony Brook, NY, USA. Kenneth.Shroyer@stonybrookmedicine.edu.
Stony Brook Medicine · USMemorial Sloan Kettering Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is a clinical need to identify novel biomarkers to improve diagnostic accuracy for the detection of urothelial tumors. The current study aimed to evaluate keratin 17 (K17), an oncoprotein that drives cell cycle progression in cancers of multiple anatomic sites, as a diagnostic biomarker of urothelial neoplasia in bladder biopsies and in urine cytology specimens. We evaluated K17 expression by immunohistochemistry in formalin-fixed, paraffin embedded tissue specimens of non-papillary invasive urothelial carcinoma (UC) (classical histological cases), high grade papillary UC (PUC-LG), low grade papillary UC (PUC-HG), papillary urothelial neoplasia of low malignant potential (PUNLMP), and normal bladder mucosa. A threshold was established to dichotomize K17 status in tissue specimens as positive vs. negative, based on the proportion of cells that showed strong staining. In addition, K17 immunocytochemistry was performed on urine cytology slides, scoring positive test results based on the detection of K17 in any urothelial cells. Mann-Whitney and receiver operating characteristic analyses were used to compare K17 expression between histologic diagnostic categories. The median proportion of K17 positive tumor cells was 70% (range 20-90%) in PUNLMP, 30% (range 5-100%) in PUC-LG, 20% (range 1-100%), in PUC-HG, 35% (range 5-100%) in UC but staining was rarely detected (range 0-10%) in normal urothelial mucosa. Defining cases in which K17 was detected in ≥10% of cells were considered positive, the sensitivity of K17 in biopsies was 89% (95% CI: 80-96%) and the specificity was 88% (95% CI: 70-95%) to distinguish malignant lesions (PUC-LG, PUC-HG, and UC) from normal urothelial mucosa. Furthermore, K17 immunocytochemistry had a sensitivity of 100% and a specificity of 96% for urothelial carcinoma in 112 selected urine specimens. Thus, K17 is a sensitive and specific biomarker of urothelial neoplasia in tissue specimens and should be further explored as a novel biomarker for the cytologic diagnosis of urine specimens.

Indexed as

ImmunohistochemistryBiomarkers, TumorCarcinomaHumansKeratin-17Neoplasm GradingPredictive Value of TestsReproducibility of ResultsUrinary Bladder NeoplasmsUrotheliumBiomarkers, TumorKeratin-17KRT17 protein, human

Identifiers

PMID30443013
OpenAlexW2901275651

What OpenQuestion holds

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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.