Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
研究概览
简要总结
The aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients
详细描述
The objective of this project is to study the circulating miRNA profiles in 40 patients with cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy individuals to assess whether these biomolecules could be used as markers of the pulmonary disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary disease. The identification of sensitive and early markers, from a non-invasive sampling could enable more effective and early treatment of CF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Cystic fibrosis (CF) (MIM#219700) who are compound heterozygous or homozygous for CF causing mutations Healthy controls non -smokers and free pulmonary disease
排除标准
- •Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations
研究组 & 干预措施
Patients without fibrosis cystic
干预措施: miRNAs isolation from blood samples of patients and control (Other)
Cystic fibrosis Patients (secondary use of samples)
干预措施: miRNAs isolation from blood samples of patients and control (Other)
Cystic fibrosis Patients
干预措施: miRNAs isolation from blood samples of patients and control (Other)
结局指标
主要结局
Comparison of miRNAs expression between Cystic Fibrosis (CF) patients and healthy controls
时间窗: After blood collection: 2 years
Compare the distributions of miRNAs expression in blood samples of CF patients and to healthy controls
次要结局
- Assesment of miRNAs expression in Cystic Fibrosis Patients depending on the pulmonary status(After blood collection 2 years)