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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01939-32 | Other Identifier | France : ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The objective is to study the phenotypic, functional and metabolomic characteristics of neutrophils circulating subpopulations in lung cancer patients, and to compare them to a control group of healthy volunteers. A blood sample will be taken before the first treatment session for the lung cancer patient and a second blood sample will be taken during the first evaluation visit.
The investigators hypothesize that there may be different circulating neutrophil subpopulations in patients with metastatic non-small cell lung cancer (NSCLC) involved in tumor progression and resistance to immunotherapy.
Immune checkpoint inhibitors (ICI) have been shown to be effective in metastatic lung cancer. Unfortunately, 80% of patients do not respond and show rapid disease progression. Identifying predictive biomarkers of response is essential for early adaptation of management. Circulating lymphocytes and neutrophils represent a biomarker (NLR), predictive of immunotherapy response, in particular via the measurement of the neutrophils /lymphocyte ratio. Some preclinical work suggests a role for circulating neutrophil subpopulations like MDSC (myeloid derived suppressor cells) in ICI resistance. Certain circulating neutrophil subpopulations are thought to promote tumor progression, angiogenesis and metastasis with immunosuppressive activity. Identifying these pro-tumor subpopulations could predict the response to ICI and could be a potential therapeutic target. Our goal is to characterize the circulating neutrophil subpopulations of lung cancer patients and correlate these characteristics with response and survival phenotypically and functionally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung cancer | Metastatic, with complete mutational status, without anterior treatment |
| |
| Chronic obstructive pulmonary disease (COPD) | Diagnosis of post-smoking COPD (without diagnosis of CP) |
| |
| Healthy volunteers | Healthy volunteers (based on biological and clinical data already available from the partner) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra blood tubes | Other | Extra blood tubes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a subpopulation of circulating neutrophils | Presence of a subpopulation of circulating neutrophils in patients with lung cancer (absent in healthy volunteers and COPD patients) with phenotypic CD45+, CD15+, CD16+, CD62L-, LOX1+ and functional immunosuppressive characteristics. | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics | Demographic characteristics : age, sex and smoking | Day 1 |
| Performans status | Somatic characteristics | Day 1 |
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Inclusion Criteria common to lung cancer and COPD patients :
Inclusion Criteria for lung cancer patients :
- Diagnosis of metastatic stage lung cancer with mutation status, naïve treatment
Inclusion Criteria for COPD patients :
- Diagnosis of COPD post-smoking
Exclusion Criteria:
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Patients with metastatic lung cancer, without anterior treatment. Inclusion during a consultation or hospitalization by a pneumologist or oncologist in the thoracic oncology unit during care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie WISLEZ, Pr | Contact | +33 1 58 41 18 89 | marie.wislez@aphp.fr | |
| Marie BENHAMMANI-GODARD | Contact | +33 1 58411190 | marie.godard@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie WISLEZ, Pr | Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit | Recruiting | Paris | Île-de-France Region | 75014 | France |
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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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Whole blood
| Stage | Somatic characteristics | Day 1 |
| Histologic type | Histologic characteristics | Day 1 |
| Mutation status | Molecular characteristics | Day 1 |
| Clinical assessment | Progression free survival (defined as the time between the start of treatment and the date of first observation of clinical or CT progression (irRECIST1.1 criterion) or death) | Up to the end of participation, between month 3 and month 4 |
| irRECIST 1.1 response | CT scan to evaluate progression free survival (defined as the time between the start of treatment and the date of first observation of clinical or CT progression (irRECIST1.1 criterion) or death) | Up to the end of participation, between month 3 and month 4 |
| Death | Progression free survival (defined as the time between the start of treatment and the date of first observation of clinical or CT progression (irRECIST1.1 criterion) or death) | Up to the end of participation, between month 3 and month 4 |
| Mortality | Overall survival (defined as the time from treatment diagnosis to the date of death). | Up to the end of participation, between month 3 and month 4 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |