NCT05024734 Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids
| NCT ID | NCT05024734 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Roland Seiler-Blarer |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-02-21 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2023-02-21 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
From patients with intermediate risk non-muscle invasive bladder cancer tumor (NMIBC) specimens will be harvested during transurethral resection. Fresh specimens will be cultured as patient derived organoids (PDO). After approx. 10 days, PDO are exposed to different drugs that are used as intravesical instillation agents in these patients (epirubicin, mitomycin, gemcitabine, docetaxel). After 2 days of exposure, PDO viability will be measured. The drug with the highest antitumor effect on PDO will be applied as weekly intravesical instillations 6 times. Thereafter, patients are followed according to the standard of care.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Signed Informed Consent Form * ECOG performance status of 0 or 1 * Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients * Representative fresh tumor specimen for PDO generation and drug screen Exclusion Criteria: * Known previous high grade and/or high risk non muscle-invasive bladder cancer * Previous Intravesical biological/immuno (BCG) therapy * Pregnancy or nursing * Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol * Severe infection within 4 weeks prior to cycle 1, day 1 * Contraindication for frequent catheterization * Voiding dysfunction * Pregnancy or nursing * Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment. * Male subject who is unwilling to use acceptable method of effective contraception during IP treatment and through 6 months after the last dose of IP.
Contact & Investigator
Roland Seiler-Blarer, MD
STUDY CHAIR
Department of Urology
Frequently Asked Questions
Who can join the NCT05024734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05024734 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05024734 currently recruiting?
Yes, NCT05024734 is actively recruiting participants. Contact the research team at urologie@szb-chb.ch for enrollment information.
Where is the NCT05024734 trial being conducted?
This trial is being conducted at Biel, Switzerland.
Who is sponsoring the NCT05024734 clinical trial?
NCT05024734 is sponsored by Roland Seiler-Blarer. The principal investigator is Roland Seiler-Blarer, MD at Department of Urology. The trial plans to enroll 34 participants.
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