Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer Undergoing Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Presence of a subpopulation of circulating neutrophils
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lung cancer
Metastatic, with complete mutational status, without anterior treatment
干预措施: Extra blood tubes (Other)
Chronic obstructive pulmonary disease (COPD)
Diagnosis of post-smoking COPD (without diagnosis of CP)
干预措施: Extra blood tubes (Other)
Healthy volunteers
Healthy volunteers (based on biological and clinical data already available from the partner)
干预措施: Extra blood tubes (Other)
结局指标
主要结局
Presence of a subpopulation of circulating neutrophils
时间窗: Through 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.
次要结局
- Stage(Day 1)
- Mutation status(Day 1)
- Performans status(Day 1)
- Clinical assessment(Up to the end of participation, between month 3 and month 4)
- Mortality(Up to the end of participation, between month 3 and month 4)
- Histologic type(Day 1)
- Demographic characteristics(Day 1)
- irRECIST 1.1 response(Up to the end of participation, between month 3 and month 4)
- Death(Up to the end of participation, between month 3 and month 4)