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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Institut Paoli-Calmettes
RECRUITING
Marseille
Contact Information
Primary
Jihane PAKRADOUNI, PharmD
drci.up@ipc.unicancer.fr
491223778
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2025-06-09
Participants
Target number of participants: 700
Related Therapeutic Areas
Sponsors
Leads: Institut Paoli-Calmettes

This content was sourced from clinicaltrials.gov