NCT06072027Completed
Evaluation of VISIOCYT Bladder Cytology in Real Life
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 701 (actual)
- First submitted
- 2 Oct 2023
- Start date
- Nov 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Bladder cancer
- NCT number
- NCT06072027
What you commit to
- Study type: Observational
- Participants enrolled: 701
- From Nov 2023 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Renal transplant patients,
- Patient having received pelvic radiotherapy,
Age
- Pregnant or potentially pregnant women (of childbearing age, without effective contraception) or nursing mothers,
Other
- Patients managed or followed up for a bladder tumor of non-urothelial histology,
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.