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

University Hospital, Lille

Status: Completed

Conditions: Systemic Sclerosis; Systemic Scleroderma

Treatments: Diagnostic Test: Skin biopsies; Diagnostic Test: Blood test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03816189

2017_10

2017-A02587-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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, ..)

Enrollment: 70 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

70 participants in 3 patient groups

Diffuse SSc

Description:

Recruitment of 20 patients with diffuse SSc

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Skin biopsies

Limited SSc

Description:

Recruitment of 20 patients with limited SSc

Treatment:

Diagnostic Test: Blood test

Diagnostic Test: Skin biopsies

Healthy subjects

Description:

Recruitment of 20 healthy subjects (control)

Treatment:

Diagnostic Test: Blood test