Stem Cell Factor, a Potential Biological Marker of Skin Involvement in Systemic Sclerosis?
1 other identifier
observational
65
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2022
CompletedFirst Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedAugust 1, 2022
July 1, 2022
1.1 years
July 29, 2022
July 29, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
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.
Control
Control patients recruited among patients followed for mechanical pathology in rheumatology.
Interventions
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 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.
Eligibility Criteria
Patients followed regularly at CHU Brugmann in Rheumatology/Dermatology for limited or diffuse systemic sclerosis in accordance with the ACR/EULAR 2013 criteria.
You may qualify if:
- 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
You may not qualify if:
- Patients with comorbidities of hematological diseases, asthma or severe chronic renal failure (GFR \< 30)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Brugmann
Brussels, 1020, Belgium
Biospecimen
Blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WEYNAND Marjolaine
CHU Brugmann
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Rhumatology Department
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 1, 2022
Study Start
January 11, 2022
Primary Completion
January 31, 2023
Study Completion
January 31, 2023
Last Updated
August 1, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share