Role of Eosinophil in Fibrogenesis of Systemic Sclerosis (EOFIB-SSC)

Role of Blood and Tissue Eosinophils in the Fibrogenesis of Systemic Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis; Systemic Scleroderma
• Intervention / Treatment: Diagnostic test: Blood test; Diagnostic test: Skin biopsies

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, ..)

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Claude Huriez, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 62 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diffuse SSc; Recruitment of 20 patients with diffuse SSc	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; Diagnostic test: Skin biopsies; 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)
Limited SSc; Recruitment of 20 patients with limited SSc	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; Diagnostic test: Skin biopsies; 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)
Healthy subjects; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline: one session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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		Baseline: one session

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Guillaume Lefevre, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Fibrosis; Eosinophil; Systemic Scleroderma
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Skin Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Fibrosis; Scleroderma, Systemic; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: 2017_10; 2017-A02587-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No