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

Bladder Cancer Clinical Trial

— VISIOCYT2  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06072027
• Other study ID #: VISIOCYT2-IPC 2020-072
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• cytology
Conventional cytology will be performed in parallel with VISIOCYT cytology in order to compare the two results.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Diagnostic performance - standard cytology	Diagnostic performance of standard cytology (sensitivity, specificity, positive predictive value, negative predictive value)	1 day
Secondary	Diagnostic performance of cystoscopy	Diagnostic performance of cystoscopy (sensitivity, specificity, positive predictive value, negative predictive value)	1 day
Secondary	Patient preference	Patient preference for different diagnostic tests (discrete choices)	1 day