Clinical trial NCT04566029: Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urothelial Carcinoma
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: European Georges Pompidou Hospital
name: ICM Montpellier
name: IUCT Oncopole (Toulouse)
name: Institut de cancérologie Strasbourg Europe
name: Institut de Cancérologie Lucien Neuwirth (Saint Etienne)
name: ICO - SITE Paul Papin
name: Centre Antoine Lacassagne
name: Institut Bergonié
name: Tenon Hospital, Paris
First posted: 2020-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are affiliated to or covered by a health insurance scheme. All patients over the age of 18.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
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
measure: Stool sample collected from patients in the "controls" group
timeFrame: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Secondary outcomes:
measure: Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "cases" group patients.
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "controls" group patients.
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
timeFrame: At the inclusion visit on Day 0
measure: Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
timeFrame: At the inclusion visit on Day 0
measure: Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
timeFrame: At the inclusion visit on Day 0
measure: Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
timeFrame: At the inclusion visit on Day 0
measure: Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
timeFrame: At the inclusion visit on Day 0
measure: Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Side-effects related to immunotherapy in "cases" group - patient's viewpoint.
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
timeFrame: At the inclusion visit on Day 0
measure: Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Side-effects related to immunotherapy in "controls" group - patient's viewpoint.
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
timeFrame: At the inclusion visit on Day 0
measure: Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
measure: Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
timeFrame: At the inclusion visit on Day 0
measure: Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
timeFrame: At the follow-up visit, 1 month +/- 7 days after inclusion
measure: Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.
timeFrame: At the end of study visit, 2 months +/- 15 days after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM parc euromedecine
state: Hérault
city: Paris
country: France
facility: Hopital Tenon ( Paris)
state: Paris Cx 20
city: Avignon
country: France
facility: Institut Sainte Cancerologie Lucien Neuwirth
state: Saint Priest En Jarez
city: Angers
country: France
facility: ICO-Site Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lyon
country: France
facility: Centre Leon Berard
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: HEGP GH Universitaire Paris Ouest
city: Strasbourg
country: France
facility: ICANS Strasbourg
city: Toulouse
country: France
facility: Iuct Oncopole
Study officials:
References: