An observational study in Bladder Cancer, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Institut Paoli-Calmettes · Observational
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 701 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor
Exclusion Criteria:
negative predictive value
negative predictive value of the VisioCyt® Bladder test. The second primary endpoint was the sensitivity of the VisioCyt® Bladder test.
Time frame: 1 day
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)
Time frame: 1 day
Diagnostic performance - standard cytology
Diagnostic performance of standard cytology (sensitivity, specificity, positive predictive value, negative predictive value)
Time frame: 1 day
Diagnostic performance of cystoscopy
Diagnostic performance of cystoscopy (sensitivity, specificity, positive predictive value, negative predictive value)
Time frame: 1 day
Patient preference
Patient preference for different diagnostic tests (discrete choices)
Time frame: 1 day
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes