Cystic FibrosisNCT03993600
New Markers of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Function in Sweat
A study testing Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) in people with Cystic Fibrosis and Biomarkers, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of the study is to identify new biomarkers of CFTR function in sweat and in sweat gland. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Biomarkers
- What is being tested?
- Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Dec 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
cliniques universitaires Saint-Luc
Brussels, 1200
Audrey Reynaerts, 003327649472 ext. 49472, audrey.reynaerts@uclouvain.be
Teresinha Leal, MD,PhD
About this study
Official title: MucoSWEATomics New Markers of CFTR Function in Sweat: Value for Diagnosis and Efficacy of Target Therapies
The aim of the study is to identify new biomarkers of CFTR function in sweat and in sweat gland.
Read the 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.
- Conditions
- Cystic Fibrosis, Biomarkers
- Being tested
- Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)
- Keywords
- cystic fibrosis, sweat, sweat glands, omics analysis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)Diagnostic test
three groups:
- Healthy volunteers
- Patients with Cystic fibrosis
- Heterozygous subjects
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Sham comparator | sweat test and skin biopsy Receives: Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) |
| Patients with Cystic fibrosis | Experimental | sweat test and skin biopsy Receives: Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) |
| Heterozygotes subjects | Experimental | sweat test and skin biopsy Receives: Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (1)
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start4 Dec 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups will be done : healthy volunteer, cystic fibrosis patient and heterozygotes subject
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Liège
- Responsible party
- Sponsor
- Investigators
- Teresinha Leal, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993600
- Sponsor's protocol ID
- 2018/09OCT/374
- Status last verified
- Mar 2021
- First submitted
- 14 May 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MucoSWEATomics New Markers of CFTR Function in Sweat: Value for Diagnosis and Efficacy of Target Therapies
- ClinicalTrials.gov ID
- NCT03993600
- Acronym / sponsor ID
- 2018/09OCT/374
- Conditions
- Cystic Fibrosis, Biomarkers
- Keywords
- cystic fibrosis, sweat, sweat glands, omics analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Université de Liège
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups will be done : healthy volunteer, cystic fibrosis patient and heterozygotes subject
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Sham comparator | Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)sweat test and skin biopsy |
| Patients with Cystic fibrosis | Experimental | Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)sweat test and skin biopsy |
| Heterozygotes subjects | Experimental | Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)sweat test and skin biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)three groups: 1. Healthy volunteers 2. Patients with Cystic fibrosis 3. Heterozygous subjects | Diagnostic test | Healthy volunteers, Heterozygotes subjects, Patients with Cystic fibrosis |
Primary outcome
Descriptive statistical analysis
Time frame: 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.
1 secondary outcome
Proteomics, peptidomics and metabolomics analysis on sweat and sweat glands
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresinha Leal, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) in people with Cystic Fibrosis and Biomarkers, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresinha Leal, MD, PhD (00 32 2 764 9473 ext. 49473, teresinha.leal@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive statistical analysis (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.