An observational study in Systemic Sclerosis and Systemic Scleroderma, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 66 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Observational
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.
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, ..)
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The active line of the Internal Medicine department (> 400 sclerodermic patients) guarantees the recruitment of 20 diffuse forms and 20 limited forms
For healthy subjects:
Exclusion Criteria for patients and controls:
Recruitment of 20 patients with diffuse SSc
Diagnostic Test: Blood test · Diagnostic Test: Skin biopsies
Recruitment of 20 patients with limited SSc
Diagnostic Test: Blood test · Diagnostic Test: Skin biopsies
Recruitment of 20 healthy subjects (control)
Diagnostic Test: Blood test
Patients in each group will have a blood sample (9x7 mL) for eosinophils isolation, study of activation markers on whole blood and serum biomarkers testing
In patients who will accept, skin biopsies will be performed in damaged and apparently normal skin, excluding fingers, hands, feet and face (biopsies are facultative)
Comparison of ECP concentrations in supernatants of eosinophils culture
Eosinophils will be sorted, stimulated in vitro for 2 hours and ECP concentration will be assessed in supernatants
Time frame: Baseline: one session
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)
MFI/% of CD69, HLA class II, CD9, CD11c, CD44, CCR3, CRTH2, IL-5R on blood eosinophils
Time frame: Baseline: one session
Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)
Whole genome, transcriptomic approach (differentially expressed genes will be identified using a fold change cutoff)
Time frame: Baseline: one session
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
Time frame: Baseline: one session
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille