Overview
European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.
Description
VisioCyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted .
The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression
Eligibility
Inclusion Criteria:
- Age ≥18 years old and autonomous
- Patient understanding national language well and able to understand the protocol.
- Patient information and informed consent signature before the start of the study
- Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account).
Exclusion Criteria:
- Patients who have had total bladder resection or bladder reconstruction
- Age <18 years old
- Person deprived of liberty or under guardianship (including curatorship)
- Bladder cancer outside of urothelial carcinoma
- Associated high urinary tract carcinoma
- Kidney transplant patient (BK virus)
- Pelvic radiotherapy patient (prostate cancer)
- Patients with or under surveillance of a muscle-infiltrating bladder tumor