Clinical trial NCT06072027: Evaluation of VISIOCYT Bladder Cytology in Real Life
Official title: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: negative predictive value
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic performance - VisioCyt® Bladder test
timeFrame: 1 day
measure: Diagnostic performance - standard cytology
timeFrame: 1 day
measure: Diagnostic performance of cystoscopy
timeFrame: 1 day
measure: Patient preference
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jihane PAKRADOUNI, PharmD
role: STUDY_DIRECTOR
References: