Evaluation of VISIOCYT Bladder Cytology in Real Life

NCT ID: NCT06072027

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2025-06-09

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.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihane PAKRADOUNI, PharmD

Role: STUDY_DIRECTOR

Institut Paoli-Calmettes

Locations

Institut Paoli-Calmettes

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jihane PAKRADOUNI, PharmD

Role: CONTACT

drci.up@ipc.unicancer.fr

491223778 ext. +33

Other Identifiers

VISIOCYT2-IPC 2020-072

Identifier Type: -

Identifier Source: org_study_id