Western Sweden Systemic Sclerosis Project (WESST)

Sahlgrenska University Hospital

Status: Enrolling

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

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07345052

WESST

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

150 participants in 2 patient groups

Healthy control

Description:

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

Treatment:

Other: No Intervention: Observational Cohort

Participants with SSc

Description:

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.

Treatment:

Other: No Intervention: Observational Cohort