Performance of CellDetect for detection of bladder cancer: Comparison with urine cytology and UroVysion

Shefer, Hila Kreizman; Masarwe, Ismael; Bejar, Jacob; Naamnih, Luna Hijazi; Gueta-Milshtein, Keren; Shalata, Adel; Hadid, Yarin; Nativ, Omri; Nativ, Ofer

doi:10.1016/j.urolonc.2022.12.012

Cited by 7 publications

(4 citation statements)

References 22 publications

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“…While a smaller observational study suggests diagnostic accuracy of UroVysion Ò FISH to be inferior to urine cytology, studies have used UroVysion Ò FISH in this context and found that these urine markers may help distinguish between patients with recurrence versus no recurrence. 17 In more recent observational studies, Bladder Epicheck Ò had improved sensitivity but decreased specificity as compared to urine cytology, indicating potential utility in conjunction with cystoscopy for surveillance of recurrent disease. 21 The rationale for postoperative instillation of intravesical chemotherapy includes both destruction of residual microscopic tumor at the site of TURBT and of tumor cells dispersed within the bladder.…”

Section: Guideline Statements Variant Histologiesmentioning

confidence: 99%

“…Additionally, an observational study utilizing a novel scoring system based upon UroVysion® (FISH) in patients who had a history of NMIBC identified an association between a positive FISH and the development of MIBC. 17 Based on these data, clinicians can use UroVysion® FISH as an early guide to predict response to intravesical BCG therapy. The utility of protein-based markers in this setting has not been well tested, but as with cytology, inflammation may also negatively impact their ability to predict response.…”

Section: Guideline Statementsmentioning

confidence: 99%

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Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment

Holzbeierlein,

Bixler,

Buckley

et al. 2024

J Urol.

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Purpose: The purpose of this American Urological Association (AUA)/Society of Urologic Oncology (SUO) guideline amendment is to provide a useful reference on the effective evidence-based treatment strategies for non-muscle invasive bladder cancer (NMIBC). Materials and Methods: In 2023, the NMIBC guideline was updated through the AUA amendment process in which newly published literature is reviewed and integrated into previously published guidelines in an effort to maintain currency. The amendment allowed for the incorporation of additional literature released since the previous 2020 amendment. The updated search gathered literature from July 2019 to May 2023. This review identified 1918 abstracts, of which 75 met inclusion criteria.When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) in support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. Results: Updates were made to statements on variant histologies, urine markers after diagnosis of bladder cancer, intravesical therapy, BCG maintenance, enhanced cystoscopy, and future directions. Further revisions were made to the methodology and reference sections as appropriate. Conclusions: This guideline seeks to improve clinicians' ability to evaluate and treat patients with NMIBC based on currently available evidence. Future studies will be essential to further support or refine these statements to improve patient care.

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Section: Guideline Statements Variant Histologiesmentioning

confidence: 99%

Section: Guideline Statementsmentioning

confidence: 99%

Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment

Holzbeierlein,

Bixler,

Buckley

et al. 2024

J Urol.

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“…The primary limitation of urine cytology is its low sensitivity, which often results in the misdiagnosis of low-grade, early-stage, and minimal tumours 2 ; it ranges from 0.0% to 10.0% in PUNLMP and varies from 16.0% to 56.0% in low-grade tumours. 5 , 32 These findings may be because PUNLMP has similar morphological characteristics as that of normal urothelial cells and it is difficult for cells of low-grade tumours and PUNLMP to exfoliate. Our PUCAS model enhanced the sensitivity of urine cytology for PUNLMP and low-grade and TaLG tumours in the validation and discordant cohorts.…”

Section: Discussionmentioning

confidence: 99%

Development and validation of an artificial intelligence-based model for detecting urothelial carcinoma using urine cytology images: a multicentre, diagnostic study with prospective validation

Wu,

Shen,

Hong

et al. 2024

eClinicalMedicine

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“…Another limitation is the fact that a study with 206 Uromonitor ® tests could not be included in the systematic review since the results were only available as an abstract from the 2023 Congress of the European Association of Urology, lacking the necessary study information [39]. Finally, in line with other UBDT studies, the studies considered for the systematic review only analyzed the diagnostic performance of the urinary test and did not examine the oncological and prognostic impact [3,[40][41][42]. Thus, it is now time to develop prospective randomized studies that assess the impact of partially urine-based versus purely cystoscopy-oriented follow-up protocols on relevant oncological endpoints and on basis of matched tissue diagnostics.…”

Section: Limitations and Perspectivesmentioning

confidence: 99%

Urine-Based Biomarker Test Uromonitor® in the Detection and Disease Monitoring of Non-Muscle-Invasive Bladder Cancer—A Systematic Review and Meta-Analysis of Diagnostic Test Performance

Kravchuk,

Wolff,

Gilfrich

et al. 2024

Cancers

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Optimal urine-based diagnostic tests (UBDT) minimize unnecessary follow-up cystoscopies in patients with non-muscle-invasive bladder-cancer (NMIBC), while accurately detecting high-grade bladder-cancer without false-negative results. Such UBDTs have not been comprehensively described upon a broad, validated dataset, resulting in cautious guideline recommendations. Uromonitor®, a urine-based DNA-assay detecting hotspot alterations in TERT, FGFR3, and KRAS, shows promising initial results. However, a systematic review merging all available data is lacking. Studies investigating the diagnostic performance of Uromonitor® in NMIBC until November 2023 were identified in PubMed, Embase, Web-of-Science, Cochrane, Scopus, and medRxiv databases. Within aggregated analyses, test performance and area under the curve/AUC were calculated. This project fully implemented the PRISMA statement. Four qualifying studies comprised a total of 1190 urinary tests (bladder-cancer prevalence: 14.9%). Based on comprehensive analyses, sensitivity, specificity, positive-predictive value/PPV, negative-predictive value/NPV, and test accuracy of Uromonitor® were 80.2%, 96.9%, 82.1%, 96.6%, and 94.5%, respectively, with an AUC of 0.886 (95%-CI: 0.851–0.921). In a meta-analysis of two studies comparing test performance with urinary cytology, Uromonitor® significantly outperformed urinary cytology in sensitivity, PPV, and test accuracy, while no significant differences were observed for specificity and NPV. This systematic review supports the use of Uromonitor® considering its favorable diagnostic performance. In a cohort of 1000 patients with a bladder-cancer prevalence of ~15%, this UBDT would avert 825 unnecessary cystoscopies (true-negatives) while missing 30 bladder-cancer cases (false-negatives). Due to currently limited aggregated data from only four studies with heterogeneous quality, confirmatory studies are needed.

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Performance of CellDetect for detection of bladder cancer: Comparison with urine cytology and UroVysion

Cited by 7 publications

References 22 publications

Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment

Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment

Development and validation of an artificial intelligence-based model for detecting urothelial carcinoma using urine cytology images: a multicentre, diagnostic study with prospective validation

Urine-Based Biomarker Test Uromonitor® in the Detection and Disease Monitoring of Non-Muscle-Invasive Bladder Cancer—A Systematic Review and Meta-Analysis of Diagnostic Test Performance

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