Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas
NCT ID: NCT04566029
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-12-12
2022-11-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Patients who have been responding to treatment for a long time
Blood test
The patients' blood will be collected in four 5mL heparinized tubes
Stool sample
The patients' stools will be collected at home
Questionnaires
At each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE
Controls
Patients who do not respond to treatment
Blood test
The patients' blood will be collected in four 5mL heparinized tubes
Stool sample
The patients' stools will be collected at home
Questionnaires
At each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE
Interventions
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Blood test
The patients' blood will be collected in four 5mL heparinized tubes
Stool sample
The patients' stools will be collected at home
Questionnaires
At each visit, the following questionnaires will be collected: QLQ-C30 and EQ5D-5L Appendix 16.2 and PRO CTCAE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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European Georges Pompidou Hospital
OTHER
ICM Montpellier
UNKNOWN
IUCT Oncopole (Toulouse)
UNKNOWN
Institut de cancérologie Strasbourg Europe
OTHER
Institut de Cancérologie Lucien Neuwirth (Saint Etienne)
UNKNOWN
ICO - SITE Paul Papin
UNKNOWN
Centre Antoine Lacassagne
OTHER
Institut Bergonié
OTHER
Tenon Hospital, Paris
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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ICM parc euromedecine
Montpellier, Hérault, France
Hopital Tenon ( Paris)
Paris, Paris Cx 20, France
Institut Sainte Cancerologie Lucien Neuwirth
Avignon, Saint Priest En Jarez, France
ICO-Site Paul Papin
Angers, , France
Institut Bergonié
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
HEGP GH Universitaire Paris Ouest
Paris, , France
ICANS Strasbourg
Strasbourg, , France
Iuct Oncopole
Toulouse, , France
Countries
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References
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Annakib 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.
Annakib 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.
Other Identifiers
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2020-A01224-35
Identifier Type: OTHER
Identifier Source: secondary_id
NIMAO2019_2
Identifier Type: -
Identifier Source: org_study_id
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