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

NCT03993600 | Unknown

• 1 other identifier: 2018/09OCT/374
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis; Biomarkers

Keywords

cystic fibrosis; sweat; sweat glands; omics analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proteomics, peptidomics and metabolomics analysis on sweat and sweat glands

  2 years

Study Arms (3)

Healthy volunteers

SHAM COMPARATOR

sweat test and skin biopsy

Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

Patients with Cystic fibrosis

EXPERIMENTAL

sweat test and skin biopsy

Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

Heterozygotes subjects

EXPERIMENTAL

sweat test and skin biopsy

Diagnostic Test: Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)

Interventions

Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy) DIAGNOSTIC_TEST

three groups: 1. Healthy volunteers 2. Patients with Cystic fibrosis 3. Heterozygous subjects

Healthy volunteers; Heterozygotes subjects; Patients with Cystic fibrosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Université de Liège: collaborator

Study Sites (1)

cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Teresinha Leal, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresinha Leal, MD, PhD

CONTACT

00 32 2 764 9473; teresinha.leal@uclouvain.be

Audrey Reynaerts

CONTACT

00 32 2 764 9472; audrey.reynaerts@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups will be done : healthy volunteer, cystic fibrosis patient and heterozygotes subject

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: June 20, 2019
• Study Start: December 4, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)