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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,360
The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
Hôpital d'Antony
Antony, France
Clinique " la Châtaigneraie "
Beaumont, France
CHU de Besançon
Besançon, France
Identification and classification of cells with the VisioCyt test to create an image processing algorithm
\* Identification and classification of cells, taking the Paris System in 2016 as a referential
Time frame: 9 months
Identification of presence or absence of a membrane fluorescence perished with the VisioCyt test to create an image processing algorithm
presence or absence of a membrane fluorescence perished, on slides
Time frame: 9 months
sensitivity of urinalysis by VisioCyt test
number of patients "declared positive" with the VisioCyt test among the patients actually suffering from bladder carcinoma
Time frame: through the study completion
specificity of urinalysis by VisioCyt test
number of patients "declared negative" with the VisioCyt test among the really healthy patients
Time frame: through the study completion
sensitivity of urinalysis by VisioCyt test according to the cell grade of the patients
number of patients "declared positive" with the VisioCyt test among the patients with a "low grade" or "high grade" bladder carcinoma
Time frame: through the study completion
sensitivity of urinalysis by VisioCyt test according to medical history of the patients
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
Time frame: through the study completion
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CHU de Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Edouard Herriot
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Clinique BeauSoleil
Montpellier, France
Hôtel Dieu, CHR de Nantes
Nantes, France
CHU Caremeau, Nimes
Nîmes, France
Hôpital Cochin
Paris, France
...and 4 more locations
comparison of the sensitivity of the urinalysis by VisioCyt test versus conventional urine cytology
number of patients "declared positive" with the VisioCyt test versus patients "declared positive" with the conventional urine cytology
Time frame: through the study completion
comparison of the specificity urinalysis by VisioCyt test versus conventional urine cytology
number of patients "declared negative" with the VisioCyt test versus patients "declared negative" with the conventional urine cytology
Time frame: through the study completion