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

Trial 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

NCT ID: NCT06072027

Condition: Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: cytology
Description: Conventional cytology will be performed in parallel with VISIOCYT cytology in order to compare the two results.
Arm group label: cytology

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 1, 2023

Completion date: November 30, 2024

Lead sponsor:
Agency: Institut Paoli-Calmettes
Agency class: Other

Source: Institut Paoli-Calmettes

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06072027