NCT06072027

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

October 2, 2023

Last Update Submit

March 18, 2026

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Diagnostic performance - VisioCyt® Bladder test

    1 day

  • Diagnostic performance - standard cytology

    1 day

  • Diagnostic performance of cystoscopy

    1 day

  • Patient preference

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient to undergo cystoscopy for diagnosis (suspected bladder tumor) or follow-up of bladder tumor

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jihane PAKRADOUNI, PharmD

    Institut Paoli-Calmettes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

November 8, 2023

Primary Completion

August 4, 2025

Study Completion

August 4, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

FR(1)