Immune Response Under Immunotherapy in Metastatic NSCLC: Sputum, Blood Samples and Microbioata Study
NCT ID: NCT04804137
Last Updated: 2024-01-17
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
24 participants
OBSERVATIONAL
2021-05-03
2023-07-31
Brief Summary
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Detailed Description
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The investigators therefore assume that the immune response in place during immunotherapy treatment differs according to the profile of patient response to immunotherapy.
The main objective of this project is to describe local and systemic anti-tumor immune system of patients responders or not to immune checkpoint inhibitors, but also whether the immunological characterization of sputum could be a reflection of the microenvironment tumor. The secondary objective is to study the intestinal microbiota tract of patients receiving immunotherapy, depending on their consumption of antibiotics, and compare it to the pulmonary microbiota.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group
adult patients with adenocarcinoma type non-small cell lung cancer
Blood
Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy.
sputum
induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy.
saliva
spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy.
stool
Stool analyses will be carried out on a sample taken by the patient at home and brought back at the time of a day hospital.
Interventions
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Blood
Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy.
sputum
induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy.
saliva
spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy.
stool
Stool analyses will be carried out on a sample taken by the patient at home and brought back at the time of a day hospital.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of metastatic NSCLC (Stage IV) adenocarcinoma only
* Absence of oncogenic addiction (EGFR, ALK, ROS1, RET, MET, BRAF)
* Treatment with ICI anti-PD1 or anti-PDL1 (pembrolizumab or atezolizumab) as 1st line treatment alone or in combination with chemotherapy and/or anti-angiogenic (bevacizumab).
* 1st injection of ICI, whether or not combined with chemotherapy
Exclusion Criteria
* Pregnant or breastfeeding women
* NSCLC of the epidermal or undifferentiated type
* Opposition to data processing
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Marion FERREIRA
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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Ferreira Marion
Los Angeles, California, United States
University hospital
Tours, , France
Countries
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Other Identifiers
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RIPH3-RNI20-RICEPS
Identifier Type: -
Identifier Source: org_study_id
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