Bladder Cancer
Conditions
Brief 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.
Interventions
OTHERVisioCyt® diagnostic test
The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
Sponsors
FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
SATT Paris Saclay
Vitadx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| specificity of urinalysis by VisioCyt test | through the study completion | number of patients declared negative with the VisioCyt test among the really healthy patients |
| Identification and classification of cells with the VisioCyt test to create an image processing algorithm | 9 months | \* Identification and classification of cells, taking the Paris System in 2016 as a referential |
| Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm | 9 months | presence or absence of a membrane fluorescence perished, on slides |
| sensitivity of urinalysis by VisioCyt test | through the study completion | number of patients declared positive with the VisioCyt test among the patients actually suffering from bladder carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients | through the study completion | number of patients declared positive with the VisioCyt test among the patients with a low grade or high grade bladder carcinoma |
| sensitivity of urinalysis by VisioCyt test according to medical history of the patients | through the study completion | number of patients declared positive with the VisioCyt test among the patients with a first diagnosis of bladder carcinoma or among patients with a previous bladder carcinoma under monitoring |
| comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology | through the study completion | number of patients declared positive with the VisioCyt test versus patients declared positive with the conventional urine cytology |
| comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology | through the study completion | number of patients declared negative with the VisioCyt test versus patients declared negative with the conventional urine cytology |
Countries
France
Outcome results
None listed