Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
研究概览
简要总结
Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are characterized by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognosis features are highly variable and heterogeneous. A precise phenotyping is a key-element to better understanding the pathophysiology of these chronic inflammatory diseases and to develop innovative treatment strategies.
The objectives of this prospective study is to analyze the clinical, demographic, biological, morphological, pathological, and microbiological characteristics in a cohort of patients diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical, demographic, biological, morphological, pathological, and microbiological features will be assessed.
The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a monocentric study conducted at the University Hospital of Reims, France. Adult patients (>18 year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD, bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed consent for inclusion. Exclusion criteria include "subjects protected by the law" as required by the French authorities. Control patients with no respiratory diseases after clinical and pulmonary function tests assessment will be also included. The expected number of patients included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50). Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019 (9/30/2019).
For all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care with no specific therapeutic intervention. For control patients, data will be registered at inclusion with no follow-up.
Data will be registered in a centralized anonymized database. The characteristics of the patients will be described as mean and standard deviation for quantitative data and as number and percentages for qualitative data. Comparisons and associations between groups and variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as applicable. A p<0.05 will be considered as significant.
This study should help to better characterize clinical, demographic, biological, morphological, pathological, and microbiological characteristics and phenotypes in chronic inflammatory respiratory diseases.
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
- 是
入选标准
- •Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD
排除标准
- •<18 year-old
研究组 & 干预措施
controls
干预措施: histology (Biological)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: Clinical assessment (Other)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: questionnaires (Behavioral)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: pulmonary function test (Other)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: blood test (Biological)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: microbiology (Biological)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: histology (Biological)
Chronic Obstructive Pulmonary disease (COPD)
干预措施: imaging (Other)
Cystic Fibrosis (CF)
干预措施: Clinical assessment (Other)
Cystic Fibrosis (CF)
干预措施: questionnaires (Behavioral)
Cystic Fibrosis (CF)
干预措施: pulmonary function test (Other)
Cystic Fibrosis (CF)
干预措施: blood test (Biological)
Cystic Fibrosis (CF)
干预措施: microbiology (Biological)
Cystic Fibrosis (CF)
干预措施: histology (Biological)
Cystic Fibrosis (CF)
干预措施: imaging (Other)
bronchiectasis
干预措施: Clinical assessment (Other)
bronchiectasis
干预措施: questionnaires (Behavioral)
bronchiectasis
干预措施: pulmonary function test (Other)
bronchiectasis
干预措施: blood test (Biological)
bronchiectasis
干预措施: microbiology (Biological)
bronchiectasis
干预措施: histology (Biological)
bronchiectasis
干预措施: imaging (Other)
Interstitial lung disease (ILD)
干预措施: Clinical assessment (Other)
Interstitial lung disease (ILD)
干预措施: questionnaires (Behavioral)
Interstitial lung disease (ILD)
干预措施: pulmonary function test (Other)
Interstitial lung disease (ILD)
干预措施: blood test (Biological)
Interstitial lung disease (ILD)
干预措施: microbiology (Biological)
Interstitial lung disease (ILD)
干预措施: histology (Biological)
Interstitial lung disease (ILD)
干预措施: imaging (Other)
controls
干预措施: Clinical assessment (Other)
controls
干预措施: questionnaires (Behavioral)
controls
干预措施: pulmonary function test (Other)
controls
干预措施: blood test (Biological)
controls
干预措施: microbiology (Biological)
controls
干预措施: imaging (Other)
结局指标
主要结局
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
时间窗: up to 10 years
次要结局
未报告次要终点
