Inflammatory markers in Broncho-alveolar Lavage fluid as risk factors for Lung disease in infants with Cystic Fibrosis: the I-BALL study
Completed
- Conditions
- CFCystic fibrosis1008362410024967
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Subjects are eligible for this study when:
- They are diagnosed with CF, confirmed with 2 mutations found by genetic analysis, either from heel prick screening or diagnosed later in life.
- Aged 1, 3 or 5 years, when they will undergo bronchoscopy and chest CT scan as part of the routine monitoring program for CF.
- Authorized by an informed consent from parents to undergo a possible extra rinse during bronchoscopy to retrieve sufficient BALF, an extra blood sample of 2 ml during the routine venous puncture, and permission to use excess biomaterials and coded clinical data for research.
Exclusion Criteria
Absence of previously given informed consent for use of encoded clinical data for scientific purposes
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Correlation of lipid profiles with early lung disease in CF:<br /><br>Lipidomics endpoints. The primary end-points are the different bioactive lipid<br /><br>levels in BALF of infants with CF using liquid chromatography (LC) coupled to<br /><br>Mass spectrometry (MS). Lipid profiles will be derived of the BALF supernatant<br /><br><br /><br>2. Association early lung disease in CF with airway neutrophils reprogramming:<br /><br>PMN endpoints. The primary endpoint for BALF cells flow cytometry analysis is<br /><br>surface CD63 on airway PMNs (exocytosis of NE-rich granules), which was shown<br /><br>to correlate with lung function in chronic CF disease</p><br>
- Secondary Outcome Measures
Name Time Method <p>Other study parameters: We will assess various correlations, between:<br /><br>* Bioactive lipid levels and chest CT score<br /><br>* Bioactive lipid levels and past exacerbations / past antibiotic courses<br /><br>* Bioactive lipid levels and future (after moment of samples) exacerbations /<br /><br>future antibiotic courses (Bioactive lipid levels as riskfactors for later<br /><br>problems)<br /><br>* Bioactive lipid levels and microbiome (microorganisms from BALF / nasopharynx)<br /><br>* PMN endpoints and chest CT score<br /><br>* PMN endpoints and past exacerbations / past antibiotic courses<br /><br>* PMN endpoints and future exacerbations / future antibiotic courses (PMN<br /><br>endpoints as risk factors for later problems)<br /><br>* PMN endpoints and microbiome<br /><br>* PMN endpoints and bioactive lipid levels </p><br>