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Gut bugs may hold key to immunotherapy response in bladder cancer

NCT ID NCT04566029

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed pilot study looked at whether the proteins produced by gut bacteria differ between bladder cancer patients who respond to immunotherapy and those who do not. Researchers collected stool and blood samples from 40 patients with advanced bladder cancer. The goal was to find a protein signature that could predict treatment response, potentially personalizing therapy and reducing unnecessary side effects.

What this could mean

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

What this could lead to
If successful, this could help doctors predict which bladder cancer patients will benefit from immunotherapy, avoiding unnecessary side effects and costs for non-responders.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to all patients. It is exploratory and does not test a new treatment.

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.

Participants

40 people

The number who actually took part.

Started

Dec 2020

Finished

Nov 2022

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.

Who is studied

All patients who are affiliated to or covered by a health insurance scheme. All patients over the age of 18.

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: For the "controls" group: * Patients undergoing treatment for a locally advanced or metastatic urothelial tumor * Patients who have been on immunotherapy and 2nd-line monotherapy treatment for at least 6 months for a non-operable disease * Patients whose immunotherapy has been interrupted due to progression of the disease For the "cases" group: * patients being treated in the context of a temporary authorization for use delivered for atezolizumab for the management of locally advanced or metastatic urothelial carcinomas following treatment based on platinum salts and still on treatment or patients being treated with pembrolizumab in the context of a donation for compassionate reasons (and still on treatment). Exclusion Criteria: * Patients who do not speak or read the French language. * Patients in an exclusion period determined by another study. * Patients under legal guardianship or curatorship. * Patients for whom it is impossible to give clear information to.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Urothelial carcinoma

Contacts and locations

Locations

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Leon Berard

    Lyon, 69373, France

  • HEGP GH Universitaire Paris Ouest

    Paris, 75908, France

  • Hopital Tenon ( Paris)

    Paris, Paris Cx 20, 75970, France

  • ICANS Strasbourg

    Strasbourg, 67091, France

  • ICM parc euromedecine

    Montpellier, Hérault, 34298, France

  • ICO-Site Paul Papin

    Angers, 49055, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Sainte Cancerologie Lucien Neuwirth

    Avignon, Saint Priest En Jarez, 42271, France

  • Iuct Oncopole

    Toulouse, 31059, France

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