NCT04566029

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Urothelial Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Blood test	The patients' blood will be collected in four 5mL heparinized tubes
BIOLOGICAL	Stool sample	The patients' stools will be collected at home
OTHER	Questionnaires	At each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE

Timeline

• Start date: 2020-12-12
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2020-09-28
• Last updated: 2025-12-10

Locations

10 sites across 1 country: France