New Markers of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Sweat

Cystic Fibrosis Clinical Trial

Official title:

MucoSWEATomics New Markers of CFTR Function in Sweat: Value for Diagnosis and Efficacy of Target Therapies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03993600
• Other study ID #: 2018/09OCT/374
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Teresinha Leal, MD, PhD
• Phone: 00 32 2 764 9473
• Email: teresinha.leal[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to identify new biomarkers of CFTR function in sweat and in sweat gland.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject aged of 18 years or more.

• The patients with cystic fibrosis must have a confirmed diagnosis, be clinically stable, have a Forced Expiratory Volume in one second (FEV1) = 30 and an O2 saturation = 92%. F508del homozygous will been tested.

• Heterozygosity (parents of patients) will be confirmed by the presence of a single F508del mutation.

Exclusion Criteria:

• Presence of an acute infection

• Pregnancy and lactation

• Subjects currently included in another clinical trial

• Subjects with forearm skin alterations

• Subjects with signs of dehydration

• Smokers

Related Conditions & MeSH terms

• Biomarkers
• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)
three groups: Healthy volunteers Patients with Cystic fibrosis Heterozygous subjects

Locations

Country	Name	City	State
Belgium	cliniques universitaires Saint-Luc	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Université de Liège

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	2 years