Evaluation of VISIOCYT bladder cytology in real-life settings
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
This study is testing if a new way of checking bladder cells from urine samples can help people who are having cystoscopy for suspected or existing bladder tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Paoli-Calmettes Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06072027 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of VISIOCYT bladder cytology in patients undergoing cystoscopy for suspected bladder tumors or for follow-up of existing bladder tumors. Patients will provide urine samples prior to cystoscopy, which will be analyzed using standard cytological methods and VISIOCYT cytology. The study will collect and pseudonymize clinical data to assess the performance of VISIOCYT in a real-world clinical setting, following current French guidelines for bladder cancer management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are scheduled for cystoscopy due to suspected bladder tumors or for follow-up of previously diagnosed bladder tumors.
Not a fit: Patients with non-urothelial bladder tumors, renal transplant recipients, or those who have received pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of bladder cancer diagnosis and monitoring, leading to better patient outcomes.
How similar studies have performed: While this approach is based on existing cytological techniques, the specific application of VISIOCYT in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Marseille
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Jihane PAKRADOUNI, PharmD
- Email: drci.up@ipc.unicancer.fr
- Phone: 491223778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.