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 (VISIOCYT2)

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: Not yet recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Diagnostic test: cytology

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

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?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	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

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital 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