Evaluation of VISIOCYT Bladder Cytology in Real Life (VISIOCYT2)

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Diagnostic test: cytology

• Study Type: Observational
• Enrollment (Actual): 701
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Institut Paoli-Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: cytology; classical cytology will be done, in parallel of VISIOCYT cytology, in order to be compared	Diagnostic test: cytology; Conventional cytology will be performed in parallel with VISIOCYT cytology in order to compare the two results.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Study Director: Jihane PAKRADOUNI, PharmD, Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): August 4, 2025
• Study Completion (Actual): August 4, 2025

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: VISIOCYT2-IPC 2020-072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No