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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482594
• Other study ID #: CHUB-SCF
• Status: Recruiting
• Start date: January 11, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: WEYNAND Marjolaine
• Phone: 3224773649
• Email: MarjolaineLilianeMathilde.WEYNAND[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stem Cell Factor	Stem Cell Factor blood levels	1 year
Primary	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