Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— EOFIB-SSC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03816189
• Other study ID #: 2017_10
• Secondary ID: 2017-A02587-46
• Status: Active, not recruiting
• Start date: October 3, 2018
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, ..)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Scleroderma
• Systemic Sclerosis

Intervention

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
• 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)

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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