Western Sweden Systemic Sclerosis Project - A Study on Underlying Mechanisms for Disease Development and Predictors of Disease Activity and Treatment Response in Patients With Systemic Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Predictors of disease activity and progression in plasma samples
Study Overview
Brief Summary
The main aim of the project is to identify key-factors involved in the development and progression of Systemic Sclerosis (SSc), a chronic invalidating rheumatic disease characterized by high mortality and insufficient treatment options. A cohort of patients with SSc will be collected at the Sahlgrenska University Hospital in Gothenburg, Skaraborg Hospital in Skövde, and Södra Älvsborg Hospital in Borås (Sweden). Thanks to a holistic approach including integrated analysis of blood, and skin samples as well as DNA, and with the use of state-of-the-art methods, this project aims to identify factors (e.g. genes, proteins, metabolites, and immune cell types) associated with the development of SSc and with the progression to a more aggressive phenotype. Functional studies using in vitro model systems and patient specimens will be also implemented. The findings of the current project could lead to the identification of possible diagnostic and prognostic markers for the disease as well as potential drug targets. This cohort will be also linked to the European Scleroderma Trial and Research (EUSTAR), which is an international SSc research network aiming to coordinate research activities on SSc from groups all over Europe in order to improve treatment, quality of life and mortality of patients with SSc.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants diagnosed with SSc according to the ACR and EULAR classification criteria
Exclusion Criteria
- •Diagnosis of Mixed connective tissue disease
- •Not speaking or reading Swedish
- •With severe cognitive impairment
- •With blood count below specified limits
- •Allergy to local anaesthetic (for subjects who will provide a skin biopsy)
Outcomes
Primary Outcomes
Predictors of disease activity and progression in plasma samples
Time Frame: The analyses will be performed in the entire study cohort at inclusion (including healthy subjects) and at the 2- and 5-year FU for patients with SSc.
Here we will analyse plasma circulating molecules (including but not limited to metabolites, cytokines, lipids, proteins, antibodies, exosomes etc) to identify factors involved in the pathogenesis of SSc by comparing those factors in plasma from subjects with SSc vs. healthy subjects. We also aim to identify factors involved in the prognosis of SSc by comparing circulating molecules in plasma from subjects with limited form SSc vs. diffuse form SSc. We plan to screen plasma samples from study participants for molecules that can be relevant for the pathogenesis and the prognosis of SSc.
Secondary Outcomes
- Genetic markers of progression to an aggressive phenotype in subjects with SSc(Baseline DNA)
- Characterisation of skin cells in relation to SSc pathogenesis and progression(The analyses will be performed in the entire study cohort at inclusion (including healthy subjects) and at the 2- and 5-year FU for patients with SSc.)
- Memory B cell compartment and prognosis of SSc(Baseline PBMCs)
- PBMCs subsets and activation in the pathogenesis of SSc.(Baseline, 2- and 5- years FU)
- Circulating fibrocytes and pathogenesis of SSc.(Baseline, 2- and 5- years FU)
- Arthritis involvement in SSc.(Baseline, 2- and 5-years follow up)
- Assessment of Lung Function and Biomarker Profiling in Patients with Systemic Sclerosis through PExA sampling(Up to 2 years)
- Assessment of Lung Function in Patients with Systemic Sclerosis through Insert Gas Washout(Up to 2 years)
- Assessment of Lung Function in Patients with Systemic Sclerosis through Impulse Oscillometry(Up to 2 years)
Investigators
Yuan Zhang
Researcher
Göteborg University