Clinical trial · Observational
Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas
Analysis of the Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas According to Their Response to Immunotherapy (Responders vs. Non-responders) : A Prospective Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. But only 20% of patients get any clinical benefit from these heavy treatments in the long term. Treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. It is therefore urgent and important to exceed the current criteria for using immunotherapy. Recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy. The investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood test | Biological | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Stool sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Patients who have been responding to treatment for a long time
- interventionNames
- Biological: Blood test
- Biological: Stool sample
- Other: Questionnaires
- label
- Controls
- description
- Patients who do not respond to treatment
- interventionNames
- Biological: Blood test
- Biological: Stool sample
- Other: Questionnaires
Primary outcomes (2)
- measure
- Stool sample collected from patients in the "cases" group
- timeFrame
- 24 hours before the patient's follow-up visit at 1 month +/- 7 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTAnnakib S, Fiteni F, Houede N. Quality of Life with Monoclonal Antibody Therapies for Locally Advanced or Metastatic Urothelial Carcinoma: A Systematic Review. Eur Urol Oncol. 2023 Oct;6(5):467-476. doi: 10.1016/j.euo.2023.05.001. Epub 2023 May 25. PMID 37244802
- DERIVEDAnnakib S, Di Meglio E, Dibert-Bekoy Y, Chevallier T, Roubaud G, Fournel P, Guillot A, Borchiellini D, Pouessel D, Boughalem E, Delva R, Barthelemy P, Oudard S, Thibault C, Tosi D, Houede N, Fiteni F. Patient Versus Clinician Reported Symptoms Agreement in Advanced Metastatic Bladder Cancer Patients. Cancer Med. 2025 Apr;14(8):e70896. doi: 10.1002/cam4.70896. PMID 40256972