Characterization of the Effect of G-CSF on the Interactions Between MDSC and Cancer Stem-cells in Non-small Cell Lung Cancers (CIRCUIT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Phenotype of MDSC and CSC
研究概览
简要总结
Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to immunologic (myeloid immunosuppressive cells) and non-immunologic (cancer stem- cells (CSC)) mechanisms. CSC are able to circulate within blood, protected from destruction by immunosuppressive cells such as MDSC. Some factors such as G-CSF, administered to lower febrile neutropenia, should modulate properties of MDSC and CSC, but data are contradictory, and literature remain poor regarding its effects on the interactions between MDSC and CSC in blood clusters. Indeed, this project aims at better characterizing the effect of G-CSF on these interactions and on their functions in NSCLC patients receiving G-CSF.
详细描述
MDSC, CSC and the clusters in blood from NSCLC patients will be assessed to evaluate the impact of G-CSF on their phenotype and functions. Samples from 2 groups of NSCLC patients receiving chemotherapy and immunotherapy will be used: 15 receiving concomitant G-CSF, and 15 not receiving concomitant G-CSF
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Patients (male or female) aged ≥ 18 years
- •Histological or cytological proven lung adenocarcinoma, metastatic or locally advanced not accessible to local therapy
- •Receiving chemotherapy and immunotherapy as first-line treatment
- •Signed written informed consent (no later than the day of inclusion, and before the blood sample collection)
- •Patient affiliated or beneficiary to a health security system;
排除标准
- •Patient with a small cell lung carcinoma
- •Non-metastatic disease
- •Actionable mutation or genomic alteration in EGFR, ALK or ROS1
- •Corticosteroids > 10 mg/j
- •Autoimmune disease
- •Active and uncontrolled HIV infection
- •Concomitant cancer
- •Pregnancy or lactating women
- •Psychiatric or medical conditions that prohibit the understanding and rendering of informed consent
- •Patient under a legal protection measure
- •Patient with a deprived liberty condition
- •Patient incapable of giving signed informed consent
- •Patient within the exclusion period for another clinical trial, or participating to another interventional trial within 30 days before the beginning of this project
研究组 & 干预措施
Patients receiving G-CSF
干预措施: Blood sample (Biological)
Patients without G-CSF
干预措施: Blood sample (Biological)
结局指标
主要结局
Phenotype of MDSC and CSC
时间窗: At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse
Expression of different MDSC markers corresponding to the rate of the different MDSC subpopulations
Functions of MDSC and CSC
时间窗: At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse
Immunosuppressive and non immunosuppressive functions of the different populations of MDSC
次要结局
未报告次要终点