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Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas

NCT04566029 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-12-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • European Georges Pompidou Hospital

    collaborator OTHER

  • ICM Montpellier

    collaborator UNKNOWN

  • IUCT Oncopole (Toulouse)

    collaborator UNKNOWN

  • Institut de cancérologie Strasbourg Europe

    collaborator OTHER

  • Institut de Cancérologie Lucien Neuwirth (Saint Etienne)

    collaborator UNKNOWN

  • ICO - SITE Paul Papin

    collaborator UNKNOWN

  • Centre Antoine Lacassagne

    collaborator OTHER

  • Institut Bergonié

    collaborator OTHER

  • Tenon Hospital, Paris

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-12
Primary Completion
2022-11-29
Completion
2022-11-29

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566029 on ClinicalTrials.gov