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

Not Applicable

• Conditions: Biomarkers; Cystic Fibrosis

• Registration Number: NCT03993600
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Descriptive statistical analysis	one day	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.

Secondary Outcome Measures

Name	Time	Method
Proteomics, peptidomics and metabolomics analysis on sweat and sweat glands	2 years	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).

Trial Locations

Locations (1)

cliniques universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium