NCT06227065Not yet recruitingPhase 2
Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids
POLO-Trial. Precise Neoadjuvant Chemoresection of Low-grade NMIBC Guided by Drug Sceens in Patient-derived Or-ganoids. An Open-label, Phase II Trial.
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial. The investigators aim to use drug screens in PDOs to guide neoadjuvant intravesical instillation therapy with either Epirubicin, Mitomycin C, Gemcitabine or Docetaxel to achieve chemoresection NMIBC.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 17 Jan 2024
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Nov 2030
- Lead sponsor
- Hospital Centre Biel/Bienne
- Diseases
- Bladder cancer
- NCT number
- NCT06227065
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 28
- From 1 Dec 2026 to the primary completion date, 30 Nov 2030
- 2 sites 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
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol as judged by the investigator
- Severe infection within 4 weeks prior to the date of the patient's informed consent signature
- Pregnancy or nursing. Female subject of childbearing potential (defined as premenopausal women who have not undergone surgical sterilization and are sexually active with a male part-ner) must have a negative urine pregnancy test at screening
- Concomitant participation in another interventional clinical trial with an active treatment within 4 weeks prior to the date of the patient's informed consent signature and during the current trial.
Other
- Anticoagulation other than acetylsalicylic acid
- Contraindication for frequent catheterization
- Female subject of childbearing potential who is unwilling to use effective contraception method(s) from the start of the intravesical instillation with the IMP until six months after the last instillation
- Male subject who is unwilling to use an effective contraception method from the start of the intravesical instillation with the IMP until four months after the last instillation
- Vulnerable individual, e.g., individual incapable of judgement or currently incarcerated or oth-erwise institutionalized (prisoner), or refugee
Who the study is looking for
- Signed Informed Consent Form
- Age ≥ 18 years
- Primary or recurrent NMIBC suspected to be low-grade or maximum G2 with a negative urine cytology
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lindenhofspital, Klinik für Urologie Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Spitalzentrum Biel, Klinik für Urologie Coordinator of this site? Confirm its status | Biel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.