Clinical trial NCT03816189: Role of Eosinophil in Fibrogenesis of Systemic Sclerosis
Official title: Role of Blood and Tissue Eosinophils in the Fibrogenesis of Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Systemic Scleroderma
Keywords: Eosinophil
Fibrosis
Systemic Scleroderma
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2019-01-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The active line of the Internal Medicine department (\> 400 sclerodermic patients) guarantees the recruitment of 20 diffuse forms and 20 limited forms

Brief summary: Eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. Systemic sclerosis (SSc) is an autoimmune disease with fibrotic skin and lung complications. The profibrosing properties and data from the SSc literature suggest a possible role of the eosinophils in the process of fibrogenesis of SSc.

Detailed description: it will assess the activation state of blood eosinophils in SSc patients compared to healthy controls (ECP production in vitro, surface activation markers, whole transcriptome array, ..).

it will also study skin eosinophils and their recruitment (extracellular eosinophil granules, eotaxins production in skin, ..)

Eligibility criteria: Inclusion Criteria:

* For SSc patients:
* Meeting the 2013 ACR-EULAR criteria for diffuse SSc (n = 20) and limited SSc (n = 20)
* Having signed the informed consent
* Eosinophils ≥ 0.1 G / L on the last blood test (\<3 months)

For healthy subjects:

* Without chronic pathology requiring long-term treatment
* Eosinophils between 0.1 and 0.4 G / L on recent blood test (\<3 months)

Exclusion Criteria for patients and controls:

* Patient with an infection, state of emergency or progressive neoplastic pathology
* Pregnant or lactating women
* History of atopy (allergic asthma, atopic eczema, allergic rhinitis, allergic conjunctivitis)
* Allergy to local anesthetics (for scleroderma patients only)
* Taking into account a minimum weight of 50 kg and in the absence of cardiorespiratory effects of scleroderma, only patients with at least 10 g of hemoglobin will be included

Primary outcomes:
measure: Comparison of ECP concentrations in supernatants of eosinophils culture
timeFrame: Baseline: one session
Secondary outcomes:
measure: Comparison of median fluorescence intensities of several surface markers on blood eosinophils, or comparison of percentages of positive cells among all eosinophils for a given marker (flow cytometry)
timeFrame: Baseline: one session
measure: Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)
timeFrame: Baseline: one session
measure: In skin biopsies: density of eosinophils, extracellular ECP and MBP deposits (absent in healthy skin), and density of eotaxin-1-producing cells will be assessed in damaged skin and apparently healthy skin of SSc patients
timeFrame: Baseline: one session
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Lefevre, MD
role: PRINCIPAL_INVESTIGATOR
References: