Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Effector function analysis of blood neutrophils in CF.
研究概览
简要总结
The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patient over the age of 18 who is not under legal protection
- •Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:
- •15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor
- •15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor
- •15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor
- •15 hospitalized patients for respiratory exacerbation
- •40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment.
- •No change in baseline treatment for 15 days (including antibiotic treatment).
- •Patient affiliated to a social security system
- •Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.
排除标准
- •Informed consent impossible to obtain
- •Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
结局指标
主要结局
Effector function analysis of blood neutrophils in CF.
时间窗: Through study completion, an average of 1 year
Comparison of effector function analysis of blood neutrophils of CF patients versus control blood-donors.
Phagocytosis potential of blood neutrophils in CF.
时间窗: Through study completion, an average of 1 year
Comparison of phagocytosis potential of blood neutrophils of CF patients versus control blood-donors.
Quantification of blood low density neutrophils in cystic fibrosis (CF)
时间窗: Through study completion, an average of 1 year
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are : * mature neutrophils : CD16high, CD15high, CD33high, CD10high * or Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus control blood-donors.
Survival/apoptosis balance analysis in CF
时间窗: Through study completion, an average of 1 year
Survival / apoptosis balance analysis : (PCNA localization) in CF patients blood neutrophils versus control blood-donors.
Transcriptomic analysis of blood neutrophils in cystic fibrosis (CF)
时间窗: Through study completion, an average of 1 year
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential. Comparison of transcriptomic blood neutrophil profile in CF patients versus control blood-donors.
次要结局
- Transcriptomic analysis of blood neutrophils in CF according to different clinical situations.(Through study completion, an average of 1 year)
- Quantification of blood low density neutrophils in CF vs other chronic inflammatory disorders.(Through study completion, an average of 1 year)
- Quantification of blood low density neutrophils in CF according to different clinical situations.(Through study completion, an average of 1 year)
- Phagocytosis potential of blood neutrophils in CF according to different clinical situations.(Through study completion, an average of 1 year)
- Effector function analysis of blood neutrophils in CF according to different clinical situations.(Through study completion, an average of 1 year)
- Survival/apoptosis balance analysis in CF according to different clinical situations.(Through study completion, an average of 1 year)