NCT02966691

Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,360 (actual)
• Sponsor: Vitadx · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.

Detailed description

This clinical trial is divided into two main phases: I. The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled. II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
OTHER	VisioCyt® diagnostic test	The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.

Timeline

• Start date: 2017-01-24
• Primary completion: 2020-12-31
• Completion: 2021-01-16
• First posted: 2016-11-17
• Last updated: 2022-01-06

Locations

14 sites across 1 country: France