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

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

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.

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.

Inclusion Criteria:

• Age ≥18 years

• Patient affiliated to a social security system

• Patient able to understand the protocol.

• Signature of patient consent form before the start of the study

• Negative urine culture

• Patient for which is programmed a bladder Endoscopy for :

  • suspected bladder cancer (de novo, monitoring or relapse)
  • Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer

Exclusion Criteria:

• Age <18 years
• Ongoing Urinary tract infection untreated
• Private person of liberty or under guardianship (including guardianship)
• Bladder cancer excluding urothelial carcinoma
• Carcinoma of high urinary tract, associated
• Lithiasis pathology
• Patient who underwent renal transplantation