Artificial intelligence to improve cytology performance in urothelial carcinoma diagnosis: results from validation phase of the French, multicenter, prospective VISIOCYT1 trial

PURPOSE: Cytology and cystoscopy, the current gold standard for diagnosing urothelial carcinomas, have limits: cytology has high interobserver variability with moderate or not optimal sensitivity (particularly for low-grade tumors); while cystoscopy is expensive, invasive, and operator dependent. Th...

Descripción completa

Detalles Bibliográficos
Autores principales: Lebret, Thierry, Paoletti, Xavier, Pignot, Geraldine, Roumiguié, Mathieu, Colombel, Marc, Savareux, Laurent, Verhoest, Grégory, Guy, Laurent, Rigaud, Jérome, De Vergie, Stéphane, Poinas, Grégoire, Droupy, Stéphane, Kleinclauss, François, Courtade-Saïdi, Monique, Piaton, Eric, Radulescu, Camelia, Rioux-Leclercq, Nathalie, Kandel-Aznar, Christine, Renaudin, Karine, Cochand-Priollet, Béatrix, Allory, Yves, Nivet, Sébastien, Rouprêt, Morgan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465399/
https://www.ncbi.nlm.nih.gov/pubmed/37480491
http://dx.doi.org/10.1007/s00345-023-04519-4
Descripción
Sumario:PURPOSE: Cytology and cystoscopy, the current gold standard for diagnosing urothelial carcinomas, have limits: cytology has high interobserver variability with moderate or not optimal sensitivity (particularly for low-grade tumors); while cystoscopy is expensive, invasive, and operator dependent. The VISIOCYT1 study assessed the benefit of VisioCyt(®) for diagnosing urothelial carcinoma. METHODS: VISIOCYT1 was a French prospective clinical trial conducted in 14 centers. The trial enrolled adults undergoing endoscopy for suspected bladder cancer or to explore the lower urinary tract. Participants were allocated either Group 1: with bladder cancer, i.e., with positive cystoscopy or with negative cystoscopy but positive cytology, or Group 2: without bladder cancer. Before cystoscopy and histopathology, slides were prepared for cytology and the VisioCyt(®) test from urine samples. The diagnostic performance of VisioCyt(®) was assessed using sensitivity (primary objective, 70% lower-bound threshold) and specificity (75% lower-bound threshold). Sensitivity was also assessed by tumor grade and T-staging. VisioCyt(®) and cytology performance were evaluated relative to the histopathological assessments. RESULTS: Between October 2017 and December 2019, 391 participants (170 in Group 1 and 149 in Group 2) were enrolled. VisioCyt(®)’s sensitivity was 80.9% (95% CI 73.9–86.4%) and specificity was 61.8% (95% CI 53.4–69.5%). In high-grade tumors, the sensitivity was 93.7% (95% CI 86.0–97.3%) and in low-grade tumors 66.7% (95% CI 55.2–76.5%). Sensitivity by T-staging, compared to the overall sensitivity, was higher in high-grade tumors and lower in low-grade tumors. CONCLUSION: VisioCyt(®) is a promising diagnostic tool for urothelial cancers with improved sensitivities for high-grade tumors and notably for low-grade tumors. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00345-023-04519-4.

Ejemplares similares