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临床试验/NCT02924818
NCT02924818招募中不适用

Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project

CHU de Reims1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2016年11月15日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: histology (Biological)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: Clinical assessment (Other)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: questionnaires (Behavioral)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: pulmonary function test (Other)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: blood test (Biological)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: microbiology (Biological)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: histology (Biological)

Chronic Obstructive Pulmonary disease (COPD)

Experimental

干预措施: imaging (Other)

Cystic Fibrosis (CF)

Experimental

干预措施: Clinical assessment (Other)

Cystic Fibrosis (CF)

Experimental

干预措施: questionnaires (Behavioral)

Cystic Fibrosis (CF)

Experimental

干预措施: pulmonary function test (Other)

Cystic Fibrosis (CF)

Experimental

干预措施: blood test (Biological)

Cystic Fibrosis (CF)

Experimental

干预措施: microbiology (Biological)

Cystic Fibrosis (CF)

Experimental

干预措施: histology (Biological)

Cystic Fibrosis (CF)

Experimental

干预措施: imaging (Other)

bronchiectasis

Experimental

干预措施: Clinical assessment (Other)

bronchiectasis

Experimental

干预措施: questionnaires (Behavioral)

bronchiectasis

Experimental

干预措施: pulmonary function test (Other)

bronchiectasis

Experimental

干预措施: blood test (Biological)

bronchiectasis

Experimental

干预措施: microbiology (Biological)

bronchiectasis

Experimental

干预措施: histology (Biological)

bronchiectasis

Experimental

干预措施: imaging (Other)

Interstitial lung disease (ILD)

Experimental

干预措施: Clinical assessment (Other)

Interstitial lung disease (ILD)

Experimental

干预措施: questionnaires (Behavioral)

Interstitial lung disease (ILD)

Experimental

干预措施: pulmonary function test (Other)

Interstitial lung disease (ILD)

Experimental

干预措施: blood test (Biological)

Interstitial lung disease (ILD)

Experimental

干预措施: microbiology (Biological)

Interstitial lung disease (ILD)

Experimental

干预措施: histology (Biological)

Interstitial lung disease (ILD)

Experimental

干预措施: imaging (Other)

controls

Experimental

干预措施: Clinical assessment (Other)

controls

Experimental

干预措施: questionnaires (Behavioral)

controls

Experimental

干预措施: pulmonary function test (Other)

controls

Experimental

干预措施: blood test (Biological)

controls

Experimental

干预措施: microbiology (Biological)

controls

Experimental

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

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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