Western Sweden Systemic Sclerosis Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-20

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Scleroderma, Systemic Fibrosis; Skin Fibrosis Lung Interstitial Lung Disease Due to Systemic Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy control

Participants do not have diagnosis of systemic sclerosis or other rheumatic diseases.

No Intervention: Observational Cohort

Intervention Type OTHER

no intervention

Participants with SSc

Participants with SSc will be included if they fulfil the American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) criteria for systemic sclerosis, independently of the time of the diagnosis. Subjects with mixed connective tissue disease will not be included.

No Intervention: Observational Cohort

Intervention Type OTHER

no intervention

Interventions

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No Intervention: Observational Cohort

no intervention

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes