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Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer

Recruiting
Conditions
Lung Cancer
Interventions
Other: Extra blood tubes
Registration Number
NCT06244355
Lead Sponsor
Assistance Publique - H么pitaux de Paris
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

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Exclusion Criteria
  • Tuberculosis or other acute or chronic bacterial infections
  • Chronic progressive viral infections (Hepatitis B and C, HIV)
  • Previous or ongoing chemotherapy
  • Impossibility of giving the subject informed information.
  • Opposition to the research.
  • Participation in another research study with an exclusion period still in progress at pre-inclusion (possible inclusion in an observational study)
  • Vulnerable individual (pregnant, parturient or breastfeeding woman), persons under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision)
  • Patients benefiting from the AME
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Chronic obstructive pulmonary disease (COPD)Extra blood tubesDiagnosis of post-smoking COPD (without diagnosis of CP)
Healthy volunteersExtra blood tubesHealthy volunteers (based on biological and clinical data already available from the partner)
Lung cancerExtra blood tubesMetastatic, with complete mutational status, without anterior treatment
Primary Outcome Measures
NameTimeMethod
Presence of a subpopulation of circulating neutrophilsThrough study completion, an average of 3 years

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.

Secondary Outcome Measures
NameTimeMethod
Demographic characteristicsDay 1

Demographic characteristics : age, sex and smoking

StageDay 1

Somatic characteristics

Mutation statusDay 1

Molecular characteristics

Performans statusDay 1

Somatic characteristics

Clinical assessmentUp to the end of participation, between month 3 and month 4

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)

MortalityUp to the end of participation, between month 3 and month 4

Overall survival (defined as the time from treatment diagnosis to the date of death).

Histologic typeDay 1

Histologic characteristics

irRECIST 1.1 responseUp to the end of participation, between month 3 and month 4

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)

DeathUp to the end of participation, between month 3 and month 4

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)

Trial Locations

Locations (1)

Assistance Publique - H么pitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit

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Paris, Ile De France, France

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