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OpenTrials
Completed

NCT Number: NCT06072027

Evaluation of VISIOCYT Bladder Cytology in Real Life

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. negative predictive value

    Time frame: 1 day

    negative predictive value of the VisioCyt® Bladder test. The second primary endpoint was the sensitivity of the VisioCyt® Bladder test.

Secondary outcomes

  1. Diagnostic performance - VisioCyt® Bladder test

    Time frame: 1 day

    Diagnostic performance of different algorithmic versions (V1 Versus V2) of the VisioCyt® Bladder ® test (sensitivity, specificity, positive predictive value, negative predictive value)

  2. Diagnostic performance - standard cytology

    Time frame: 1 day

    Diagnostic performance of standard cytology (sensitivity, specificity, positive predictive value, negative predictive value)

  3. Diagnostic performance of cystoscopy

    Time frame: 1 day

    Diagnostic performance of cystoscopy (sensitivity, specificity, positive predictive value, negative predictive value)

  4. Patient preference

    Time frame: 1 day

    Patient preference for different diagnostic tests (discrete choices)

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study 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

Acronym: VISIOCYT2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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