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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.
Afiliación
  • Shefer HK; Departments of Pathology, Haifa, Israel.
  • Masarwe I; Departments of Urology, Bnai Zion Medical Center, Haifa, Israel.
  • Bejar J; Departments of Pathology, Haifa, Israel.
  • Naamnih LH; Departments of Pathology, Haifa, Israel.
  • Gueta-Milshtein K; Micromedic Technologies, Tel-Aviv, Israel.
  • Shalata A; The Simon Winter Institute for Human Genetics, Bnai Zion Medical Center, Haifa, Israel.
  • Hadid Y; The Simon Winter Institute for Human Genetics, Bnai Zion Medical Center, Haifa, Israel.
  • Nativ O; Department of Urology, Rambam Medical Center, Haifa, Israel. Electronic address: _nativ@rambam.health.gov.il.
  • Nativ O; Departments of Urology, Bnai Zion Medical Center, Haifa, Israel.
Urol Oncol ; 41(6): 296.e1-296.e8, 2023 06.
Article en En | MEDLINE | ID: mdl-36642638
OBJECTIVE: To compare the performance of CellDetect, a new biomarker with urine cytology and UroVysiontechnology for bladder cancer detection. PATIENTS AND METHODS: We performed an IRB approved prospective, blinded single center study in patients on routine surveillance for nonmuscle invasive bladder cancer and those scheduled for transurethral resection of bladder tumor or radical cystectomy. Patients with bladder catheters, neobladder, ileal conduit, urinary stones, or those with upper tract carcinoma were excluded from the study. Voided urine sample was collected from the participants and each sample was divided into three equal aliquots (CellDetect, Urine cytology and Urovysion). Pathology of the operative specimen was considered the gold standard to which the three markers were compared. RESULTS: The study group included 93 patients with median age was 68 years (range: 34-92 years) with male to female ratio of 12:1. Pathologic evaluation revealed malignancy in 43 cases (46%) of whom 81% had previous history of urothelial bladder cancer. Among all studied markers CellDetect exhibited the best performance followed by urine cytology and U-FISH with diagnostic odds ratio of 4.33, 3.85, and 2.5 respectively. The overall sensitivity, specificity, negative predictive value, and positive predictive value for this test were 84%, 80%, 88%, and 74% respectively. The advantage of this new biomarker was observed both in high grade and low-grade cases. CONCLUSIONS: This study demonstrates the advantage of CellDetect as a urine-based assay to detect urothelial bladder cancer over urine cytology and U-FISH test. The high performance was maintained across all cancer grades and stages without compromising the assay specificity. Additional studies are required to test if it can be a noninvasive alternative to cystoscopy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Vejiga Urinaria / Carcinoma de Células Transicionales Tipo de estudio: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Female / Humans / Male Idioma: En Revista: Urol Oncol Asunto de la revista: NEOPLASIAS / UROLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Israel Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Vejiga Urinaria / Carcinoma de Células Transicionales Tipo de estudio: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Female / Humans / Male Idioma: En Revista: Urol Oncol Asunto de la revista: NEOPLASIAS / UROLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Israel Pais de publicación: Estados Unidos