Bladder Cancer Clinical Trial
Official title:
Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL)
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.
Status | Recruiting |
Enrollment | 33 |
Est. completion date | November 16, 2026 |
Est. primary completion date | November 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Roland Seiler | Biel |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Hospital Centre Biel/Bienne, University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with successful drug selection | ? To determine the proportion of patients for which a suitable treatment can be identified by drug screens in patient derived organoids This will establish the use of drug screens in PDOs in clinical setting and their implementation in clinical trials. | 24 months | |
Secondary | Side effects | Number of patients with side effects | 24 months | |
Secondary | Recurrence rate | Number of patients with recurrence | 42 months | |
Secondary | QoL | Quality of life will be determined using the SF-36 questionnaire | 42 months |
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