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.
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.
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.
VisioCyt® is a promising diagnostic tool for urothelial cancers with improved sensitivities for high-grade tumors and notably for low-grade tumors.
World journal of urology. 2023 Jul 22 [Epub ahead of print]
Thierry Lebret, Xavier Paoletti, Geraldine Pignot, Mathieu Roumiguié, Marc Colombel, Laurent Savareux, Grégory Verhoest, Laurent Guy, Jérome Rigaud, Stéphane De Vergie, Grégoire Poinas, Stéphane Droupy, François Kleinclauss, Monique Courtade-Saïdi, Eric Piaton, Camelia Radulescu, Nathalie Rioux-Leclercq, Christine Kandel-Aznar, Karine Renaudin, Béatrix Cochand-Priollet, Yves Allory, Sébastien Nivet, Morgan Rouprêt
Urology Department, Foch Hospital, Suresnes, France., Institut Curie, Saint Cloud, France., Urology Department, Institut Paoli-Calmettes, Marseille, France., Urology Department, Centre Hospitalier Universitaire (CHU) Rangueil, IUCT Oncopole, Toulouse, France., Urology Department, Hôpital Edouard Herriot, Lyon, France., Urology Auvergne Centre, Clinique de la Chataigneraie, Beaumont, France., Urology Department, CHU Pontchaillou, Rennes, France., Urology Department of Urology, CHU Gabriel Montpied, Clermont-Ferrand, France., Urology Department, CHU Hôtel-Dieu, Nantes, France., Urology Department, Clinique Beausoleil, Montpellier, France., Urology Department, CHU Caremeau, Nîmes, France., Urology Department, CHU Besançon, Besançon, France., Pathology and Cytology Department, CHU Toulouse, IUCT Oncopole, Toulouse, France., Centre de Pathologie Est, Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant, Bron, France., Service d'Anatomie et Cytologie Pathologiques, Hôpital Foch, Suresnes, France., Department of Pathology, CHU Pontchaillou, Rennes, France., Laboratoire d'Anatomie et Cytologie Pathologique, CHU Hôtel Dieu, Nantes, France., Department of Pathology, CHU Hôtel Dieu, Nantes, France., Department of Pathology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France., Department of Pathology, Institut Curie, Saint-Cloud, France., VitaDX International, Rennes, France. ., Urology Department, GRC n°5, Predictive ONCO-URO, Pitié-Salpêtrière Hospital, AP-HP, Sorbonne University, Paris, France.