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临床试验/NCT05482594
NCT05482594Unknown不适用

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

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年1月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
65
试验地点
1
主要终点
Stem Cell Factor

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Stem Cell Factor

时间窗: 1 year

Stem Cell Factor blood levels

Videocapillaroscopy imaging report

时间窗: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BADOT, Valerie

Head of Rhumatology Department

Brugmann University Hospital

研究点 (1)

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