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Lab-Grown tumor organoids could pick the right bladder chemo

NCT ID NCT06227065

Disease control Sponsor: Hospital Centre Biel/Bienne Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether drug testing in patient-derived organoids can guide chemotherapy for low-grade non-muscle invasive bladder cancer. Adults with primary or recurrent low-grade bladder cancer receive one of four chemo drugs, epirubicin, mitomycin C, gemcitabine, or docetaxel, instilled directly into the bladder once a week for six weeks. The goal is to see how many patients have a complete pathological response and whether the organoid drug screen is feasible and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epirubicin, Mitomycin C, Gemcitabine, or Docetaxel, chosen by lab drug testing and given into the bladder
What this could lead to
If it works, doctors could use a patient's own tumor cells to choose the most effective bladder chemo drug, possibly avoiding more invasive surgery for low-grade bladder cancer.
What could go wrong
This is a small, single-center phase 2 trial, so results may not apply broadly. The organoid drug screen may fail for some patients, and intravesical chemo can cause bladder irritation or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed Informed Consent Form 2. Age ≥ 18 years 3. Primary or recurrent NMIBC suspected to be low-grade or maximum G2 with a negative urine cytology Exclusion Criteria: 1. Anticoagulation other than acetylsalicylic acid 2. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol as judged by the investigator 3. Severe infection within 4 weeks prior to the date of the patient's informed consent signature 4. Contraindication for frequent catheterization 5. 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 6. 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 7. 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 8. Vulnerable individual, e.g., individual incapable of judgement or currently incarcerated or oth-erwise institutionalized (prisoner), or refugee 9. 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.

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma tumor grade 1, general grading system urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Low grade Non-muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lindenhofspital, Klinik für Urologie

    Bern, 3001, Switzerland

  • Spitalzentrum Biel, Klinik für Urologie

    Biel, 2501, Switzerland

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