Western Sweden Systemic Sclerosis Project

NCT07345052 | Recruiting

• 1 other identifier: WESST
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Predictors of disease activity and progression in plasma samples

  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.

  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 Outcomes (9)

• 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

Study Arms (2)

Healthy control

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

Other: No Intervention: Observational Cohort

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.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

no intervention

Healthy control; Participants with SSc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data and samples from patients diagnosed with SSc from the Sahlgrenska University Hospital in Gothenburg, Skaraborg Hospital in Skövde, and Södra Älvsborg Hospital in Borås (Sweden) as well as from healthy controls will be collected. The cohort includes 65 participants with SSc and between 27 healthy controls. * 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 diagnosis11. Participants with mixed connective tissue disease will not be included. * Healthy controls will not have diagnosis of systemic sclerosis or other rheumatic disease.

You may qualify if:

• Participants diagnosed with SSc according to the ACR and EULAR classification criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Rheumatology clinics, Sahlgrenska University Hospital

Gothenburg, Sweden, 41346, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood for DNA plasma Peripheral blood mononuclear cells (PBMC) skin fibroblasts (subgroup) keratinocytes (subgroup) skin biopsies

MeSH Terms

Conditions

Scleroderma, Systemic; Fibrosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Cristina Maglio, MD, PhD

CONTACT

0046 733231485; cristina.maglio@gu.se

Yuan Zhang, MD, PhD

CONTACT

0046 765554290; yuan.zhang@gu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 15, 2026
• Study Start: June 20, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

SE (1)