Western Sweden Systemic Sclerosis Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational Cohort.
- Who it may be relevant to
- Registry conditions: Scleroderma, Systemic, Fibrosis; Skin, Fibrosis Lung, Interstitial Lung Disease Due to Systemic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Other No Intervention: Observational Cohort
no intervention
Primary outcome measures
- 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.]
Secondary outcome measures (9)
- Genetic markers of progression to an aggressive phenotype in subjects with SSc [Time frame: Baseline DNA]
- Characterisation of skin cells in relation to SSc pathogenesis and progression [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.]
- Memory B cell compartment and prognosis of SSc [Time frame: Baseline PBMCs]
- PBMCs subsets and activation in the pathogenesis of SSc. [Time frame: Baseline, 2- and 5- years FU]
- Circulating fibrocytes and pathogenesis of SSc. [Time frame: Baseline, 2- and 5- years FU]
- Arthritis involvement in SSc. [Time frame: Baseline, 2- and 5-years follow up]
- Assessment of Lung Function and Biomarker Profiling in Patients with Systemic Sclerosis through PExA sampling [Time frame: Up to 2 years]
- Assessment of Lung Function in Patients with Systemic Sclerosis through Insert Gas Washout [Time frame: Up to 2 years]
- Assessment of Lung Function in Patients with Systemic Sclerosis through Impulse Oscillometry [Time frame: Up to 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Sweden · 1 center
- Rheumatology clinics, Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT07345052 · WESST