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Trial Title:
Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer
NCT ID:
NCT06244355
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Neutrophils
neutrophil subsets
Advanced lung cancer
biomarkers
PD-1 immunotherapy
Chronic inflammation
Phenotypic modulation
Spectral cytometry
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Extra blood tubes
Description:
Extra blood tubes
Arm group label:
Chronic obstructive pulmonary disease (COPD)
Arm group label:
Healthy volunteers
Arm group label:
Lung cancer
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria common to lung cancer and COPD patients :
- Age ≥ 18 years,
- male or female,
- affiliated with a Health Insurance,
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:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie WISLEZ, Pr
Phone:
+33 1 58 41 18 89
Email:
marie.wislez@aphp.fr
Investigator:
Last name:
Marie WISLEZ, Pr
Email:
Principal Investigator
Start date:
February 12, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244355
