Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05024734

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Spitalzentrum Biel/Bienne

Biel, Switzerland, 2501

Actively Recruiting

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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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