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NCT03816189

Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

NCT ID: NCT03816189

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-03

Study Completion Date

2022-04-05

Brief Summary

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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

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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, ..)

Conditions

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Systemic Sclerosis Systemic Scleroderma

Keywords

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Eosinophil Fibrosis Systemic Scleroderma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diffuse SSc

Recruitment of 20 patients with diffuse SSc

Blood test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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

Blood test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

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)

Blood test

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Lefevre, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02587-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_10

Identifier Type: -

Identifier Source: org_study_id