Stem Cell Factor, a Potential Biological Marker of Skin Involvement in Systemic Sclerosis?

This project aims to study systemic sclerosis and find a serum marker of its cutaneous involvement.

Systemic sclerosis (SSc) is a rare immune disease that is part of connectivitis and is characterized by fibrosis and vasculopathy. Multiple visceral lesions involving these two processes make up the severity of this disease. Its dermatological involvement is a fundamental clinical element.

Systemic sclerosis is mainly divided into two subtypes, depending on the extent of dermatological involvement: limited and diffuse systemic sclerosis. These also differ in certain autoantibody profiles and clinical features. Nevertheless, it is still necessary to determine certain criteria, markers, making it possible to distinguish at an early stage the presence of limited or diffuse systemic sclerosis. The latter being characterized by more severe organic and cutaneous involvement and excess mortality. This would allow for more aggressive management from the outset at an early onset of the disease.

In general, it is known that this pathology is characterized by dysfunction of endothelial cells (EC) and fibroblasts as well as autoimmunity. Many mediators contribute to the fibroblast activation observed in SSc. However, transforming growth factor beta (TGFβ) is considered to be the central regulatory factor of fibrosis processes.

It is also known that endothelial cells interact with mast cells through the production of Stem Cell Factor (SCF) to induce their proliferation and differentiation. The damaged skin tissues in systemic sclerosis are infiltrated in particular by mast cell cells which produce TGFβ.

The team of Kihira et al (1998) demonstrated the presence of a high level of SCF in the serum of patients with systemic sclerosis.

Few studies explore this possible production pathway of TGFβ in systemic sclerosis via SCF assay.

This study will allow the investigators to:

• study this possible route of fibrosis through the dosage of SCF in the serum of patients suffering from systemic sclerosis
• describe SCF as a possible biomarker of skin involvement by hypothesizing that the dosage of SCF will be higher in patients with diffuse scleroderma compared to those with limited scleroderma

Study Overview

• Status: Recruiting
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Diagnostic test: ELISA; Diagnostic test: Videocapillaroscopy

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: WEYNAND Marjolaine; Phone Number: 3224773649; Email: MarjolaineLilianeMathilde.WEYNAND@chu-brugmann.be
• Study Contact Backup: Name: MOSTMANS Yora; Email: Yora.MOSTMANS@chu-brugmann.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: WEYNAND Marjolaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients followed regularly at CHU Brugmann in Rheumatology/Dermatology for limited or diffuse systemic sclerosis in accordance with the ACR/EULAR 2013 criteria.

Description

Inclusion Criteria:

• Patients followed regularly at CHU Brugmann in Rheumatology/Dermatology for limited or diffuse systemic sclerosis in accordance with the ACR/EULAR 2013 criteria.
• Control patients recruited among patients followed for mechanical pathology in rheumatology

Exclusion Criteria:

• Patients with comorbidities of hematological diseases, asthma or severe chronic renal failure (GFR < 30)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Systemic sclerosis; Patients followed regularly at CHU Brugmann in rheumatology/Dermatology for limited or diffuse systemic sclerosis in accordance with the ACR/EULAR 2013 criteria.	Diagnostic test: ELISA; During routine blood sampling, serum after centrifugation will be stored and frozen at -80°C in the immunology laboratory in order to carry out analyzes by the ELISA method to measure the levels of SCF.; Diagnostic test: Videocapillaroscopy; Videocapillaroscopy is a non-invasive and safe method for the morphological examination and the analysis of abnormalities of the microcirculation linked in particular to systemic scleroderma. Here it is a digital capillaroscopy used routinely at the CHU Brugmann, in the follow-up of patients and whose results will be collected in this study.
Control; Control patients recruited among patients followed for mechanical pathology in rheumatology.	Diagnostic test: ELISA; During routine blood sampling, serum after centrifugation will be stored and frozen at -80°C in the immunology laboratory in order to carry out analyzes by the ELISA method to measure the levels of SCF.; Diagnostic test: Videocapillaroscopy; Videocapillaroscopy is a non-invasive and safe method for the morphological examination and the analysis of abnormalities of the microcirculation linked in particular to systemic scleroderma. Here it is a digital capillaroscopy used routinely at the CHU Brugmann, in the follow-up of patients and whose results will be collected in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stem Cell Factor	Stem Cell Factor blood levels	1 year
Videocapillaroscopy imaging report	Videocapillaroscopy is a non-invasive and safe method for the morphological examination and the analysis of abnormalities of the microcirculation linked in particular to systemic scleroderma.	1 year

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: WEYNAND Marjolaine, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: CHUB-SCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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