Artificial intelligence to improve cytology performance in urothelial carcinoma diagnosis: results from validation phase of the French, multicenter, prospective VISIOCYT1 trial
Thierry Lebrét, Xavier Paolettí, G. Pignot, M. Roumiguié, Marc Colombel, L. Savareux, G. Verhoest, Laurent Guy, J. Rigaud, S. De Vergie, G. Poinas, S. Droupy, F. Kleinclauss, Monique Courtade‐Saïdi, Éric Piaton, C. Radulescu, Nathalie Rioux-Leclercq, Christine Kandel-Aznar, Karine Renaudin, Béatrix Cochand‐Priollet, Yves Allory, Sébastien Nivet, Morgan Rouprêt
Abstract
Abstract 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.