NCT05024734Active, not recruitingPhase 2
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids
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)
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 23 Aug 2021
- Start date
- 21 Feb 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Roland Seiler-Blarer
- Diseases
- Bladder cancer
- NCT number
- NCT05024734
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 21 Feb 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known previous high grade and/or high risk non muscle-invasive bladder cancer
- Previous Intravesical biological/immuno (BCG) therapy
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
- Severe infection within 4 weeks prior to cycle 1, day 1
Other
- Pregnancy or nursing
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Spitalzentrum Biel/Bienne Coordinator of this site? Confirm its status | Biel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.