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| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
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Prospective pathophysiological exploratory monocentric study, focusing on adult patients with non-small cell lung cancer (NSCLC) : non-squamous type without oncogenic addiction, metastatic, treated with immune checkpoint inhibitors alone or in combination with chemotherapy in front line at the CHRU de Tours, France.
The percentage of patients benefiting from immunotherapy is quite low and their systemic side effects can sometimes be severe. One of the main difficulties is to identify before treatment patients who will respond to immune checkpoint inhibitors. Currently, the selection is done in a very large majority of cases on the expression of PD-L1 by the tumor. But this biomarker is not sufficient to identify patients responding or not to immune checkpoint inhibitors. In addition, factors extrinsic to the tumor, to its microenvironment and patient immunity may be involved in the response to immunotherapy such as the microbiota.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group | adult patients with adenocarcinoma type non-small cell lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood | Other | Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune and inflammatory response in the blood |
| 30 months |
| Immune and inflammatory response in the airways |
| 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of gut microbiota | characterisation of gut microbiota (16S rRNA sequencing) | 30 months |
| Analysis of lung microbiota | characterisation of lung microbiota (16S rRNA sequencing) |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients suffering from adenocarcinoma type non-small cell lung cancer (NSCLC) without oncogenic addiction, metastatic, treated by ICI alone or in combination with 1st line chemotherapy at the Tours CHRU.
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| Name | Affiliation | Role |
|---|---|---|
| Marion FERREIRA | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferreira Marion | Los Angeles | California | 90048 | United States | ||
| University hospital |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003672 | Defecation |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood sample, stool, saliva, sputum
| sputum | Other | induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy. |
|
| saliva | Other | spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy. |
|
| stool | Other | 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. |
|
| 30 months |
| perform blood pembrolizumab assays. | antibodies dosage | 30 months |
| perform sputum pembrolizumab assays. | antibodies dosage | 30 months |
| Tours |
| 37000 |
| France |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |