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| Name | Class |
|---|---|
| Université de Liège | OTHER |
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The aim of the study is to identify new biomarkers of CFTR function in sweat and in sweat gland.
Sweat is a watery solution containing trace amounts of proteins and peptides that may contribute to the antimicrobial defense system of the skin barrier, playing a role in innate immune responses against potential pathogens. The peptide and metabolite composition of sweat has not been fully explored. Evidence suggests that the composition of the skin barrier could vary with diseases. The causes and consequences of the changes of sweat proteins and peptides in humans are unknown. This clinical trial will focus on multiomics analysis of sweat, mainly of the antimicrobial peptides that play a key role in the host-pathogen interaction. Antioxidants, anti-bacterial and anti-inflammatory compounds may contribute to the regulation of systemic inflammation and pathophysiological disorders. In cystic fibrosis, inflammatory responses are altered, exaggerated and persistent, even in the absence of infection. It is therefore relevant to study the influence of CFTR mutations on the profile of antimicrobial peptides expressed in sweat. The clinical study will potentially lead to the discovery of novel non-invasive biomarkers of the disease in sweat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Sham Comparator | sweat test and skin biopsy |
|
| Patients with Cystic fibrosis | Experimental | sweat test and skin biopsy |
|
| Heterozygotes subjects | Experimental | sweat test and skin biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) | Diagnostic Test | three groups:
|
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive statistical analysis | The assessment of the quantity of sweat secreted will be measured in mg with a scale, the sweat chloride concentration will be done by coulometric titration and expressed in mmol/L. | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomics, peptidomics and metabolomics analysis on sweat and sweat glands | The quantity of total protein will be analysed with a colorimetric assay and will be expressed in mg/ml. The identification of the different protein will be performed with different software, databases and algorithms such as Proteome Discoverer (version 1.4.1.14), Mascot software (version 2.2.0.6), MaxQuant (version 1.5.2.8), Andromeda, Uniprot, LFQ and Perseus (version 1.5.0.15). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresinha Leal, MD, PhD | Contact | 00 32 2 764 9473 | 49473 | teresinha.leal@uclouvain.be |
| Audrey Reynaerts | Contact | 00 32 2 764 9472 | 49472 | audrey.reynaerts@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Teresinha Leal, MD, PhD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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Three groups will be done : healthy volunteer, cystic fibrosis patient and heterozygotes subject
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| 2 years |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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