Brief Title
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
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.
Study Type
Observational
Primary Outcome
Stool sample collected from patients in the "cases" group
Secondary Outcome
Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "cases" group patients.
Condition
Urothelial Carcinoma
Intervention
Blood test
Study Arms / Comparison Groups
Cases
Description: Patients who have been responding to treatment for a long time
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
40
Start Date
December 2, 2020
Completion Date
June 1, 2023
Primary Completion Date
December 30, 2022
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +33 4 66 68 33 01, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04566029
Organization ID
NIMAO2019_2
Responsible Party
Sponsor
Study Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Centre Leon Berard
Study Sponsor
, ,
Verification Date
September 2020