Actively Recruiting
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids
Led by Roland Seiler-Blarer · Updated on 2025-03-11
34
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
Sponsors
R
Roland Seiler-Blarer
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 64 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)
- Representative fresh tumor specimen available for PDO generation and drug screening
You will not qualify if you...
- 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 affecting protocol compliance
- Severe infection within 4 weeks prior to study treatment
- Contraindication for frequent catheterization
- Voiding dysfunction
- Female subjects of childbearing potential unwilling to use effective contraception during and 6 months after treatment
- Male subjects unwilling to use effective contraception during and 6 months after treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Spitalzentrum Biel/Bienne
Biel, Switzerland, 2501
Actively Recruiting
Research Team
R
Roland Seiler-Blarer, MD
CONTACT
M
Martina Schneider, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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