EVALUATION OF THE REAL-LIFE CONTRIBUTION OF VISIOCYT® BLADDER CYTOLOGY IN PATIENTS WITH SUSPECTED BLADDER TUMOR OR IN THE FOLLOW-UP OF A BLADDER TUMOR

Study Overview
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Brief Summary
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The study will be offered to all consecutive patients undergoing scheduled cystoscopy at the Hospitalisation De Jour (HDJ) Chirurgicale, either as part of a diagnostic approach in the event of suspected bladder tumor (exploration of macroscopic hematuria in particular), or as part of the follow-up of a bladder tumor, according to current recommendations (French ccAFU guidelines - update 2020-2022: bladder cancer). Once non-opposition has been obtained, clinical data at the time of inclusion will be collected and pseudonymized. Urine is collected prior to cystoscopy, on voided urine, for a minimum sufficient quantity of 50 ml. The urine sample is then separated into transport jars, one of which is used for standard cytological analysis, the other for VISIOCYT cytology (sent to a laboratory platform). In the event of a tumor or suspicious lesion detected at the cystoscopy, a trans-urethral bladder resection (TURB) will be scheduled. Anatomopathological data from this RTUV will also be collected for comparative analysis to establish the diagnostic performance of the test. The tests performed (apart from the urine sample) are part of the usual care pathway. No additional visits will be specifically requested by the protocol. Data from examinations carried out as part of standard pathology management, or suspected pathology, will be used for this research. At the same time, prospective questionnaires on patients' preferences with regard to the various diagnostic examinations for bladder tumours (discrete choice analysis) will be given to patients and completed at the time of cystoscopy.

Official Title
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EVALUATION OF THE REAL-LIFE CONTRIBUTION OF VISIOCYT® BLADDER CYTOLOGY IN PATIENTS WITH SUSPECTED BLADDER TUMOR OR IN THE FOLLOW-UP OF A BLADDER TUMOR

Conditions
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Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: cytology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years of age, Signed consent to participate, Affiliation with a social security scheme, or beneficiary of such a scheme, Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor Exclusion Criteria: Patients managed or followed up for a bladder tumor of non-urothelial histology, Renal transplant patients, Patient having received pelvic radiotherapy, Pregnant or potentially pregnant women (of childbearing age, without effective contraception) or nursing mothers, Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express consent, Inability to undergo medical follow-up for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cytology<br>classical cytology will be done, in parallel of VISIOCYT cytology, in order to be compared | Diagnostic Test: cytology<br>* Conventional cytology will be performed in parallel with VISIOCYT cytology in order to compare the two results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| negative predictive value | negative predictive value of the VisioCyt® Bladder test. The second primary endpoint was the sensitivity of the VisioCyt® Bladder test. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance - VisioCyt® Bladder test | Diagnostic performance of different algorithmic versions (V1 Versus V2) of the VisioCyt® Bladder ® test (sensitivity, specificity, positive predictive value, negative predictive value) | 1 day | 
| Diagnostic performance - standard cytology | Diagnostic performance of standard cytology (sensitivity, specificity, positive predictive value, negative predictive value) | 1 day | 
| Diagnostic performance of cystoscopy | Diagnostic performance of cystoscopy (sensitivity, specificity, positive predictive value, negative predictive value) | 1 day | 
| Patient preference | Patient preference for different diagnostic tests (discrete choices) | 1 day |