NCT03816189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

December 18, 2018

Last Update Submit

December 16, 2025

Conditions

Systemic SclerosisSystemic Scleroderma

Keywords

EosinophilFibrosisSystemic Scleroderma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

    Baseline: one session

  • Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)

    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

Study Arms (3)

Diffuse SSc

Recruitment of 20 patients with diffuse SSc

Diagnostic Test: Blood testDiagnostic Test: Skin biopsies

Limited SSc

Recruitment of 20 patients with limited SSc

Diagnostic Test: Blood testDiagnostic Test: Skin biopsies

Healthy subjects

Recruitment of 20 healthy subjects (control)

Diagnostic Test: Blood test

Interventions

Blood testDIAGNOSTIC_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

Diffuse SScHealthy subjectsLimited SSc
Skin biopsiesDIAGNOSTIC_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)

Diffuse SScLimited SSc

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Eosinophils, tissue

MeSH Terms

Conditions

Scleroderma, SystemicFibrosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Guillaume Lefevre, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

January 25, 2019

Study Start

October 3, 2018

Primary Completion

April 5, 2022

Study Completion

April 5, 2022

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)