Scleroderma, SystemicWESSTNCT07345052
Western Sweden Systemic Sclerosis Project
An observational study of Scleroderma, Systemic and Fibrosis; Skin, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma, Systemic, Fibrosis; Skin, Fibrosis Lung
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 20 Jun 2022to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Participants diagnosed with SSc according to the ACR and EULAR classification criteria
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Rheumatology clinics, Sahlgrenska University Hospital
Gothenburg, Sweden, 41346
Cristina Maglio, Doctor of Medicine, 0046733231485, cristina.maglio@gu.se
cristina.maglio@gu.se
About this study
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
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
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Scleroderma, Systemic, Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Participants do not have diagnosis of systemic sclerosis or other rheumatic diseases. Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
all DNA samples from our cohort will be subjects to either next generation sequencing or GWAS as well as epigenetic studies. Single nucleotide polymorphisms of interest will also analysed in these specimens. Data will be analysed independently and/or merged with those of other large cohorts from all over Europe to identify genetic factors associated with the development of SSc as well as the prognosis and the response to treatment.
Measured: Baseline DNA
Characterisation of skin cells in relation to SSc pathogenesis and progression
Here we will study skin cells involved in the fibrotic processes in the skin, i.e. fibroblasts and keratinocytes, as well as skin immune cells. We aim to define factors that trigger the fibroblasts to switch to a pro-fibrotic phenotype and factors associated with the progression of the skin disease. Fibroblasts, keratinocytes and immune cells will be isolated and cultured from skin biopsies. Metabolomics, lipidomics, and proteomics will be performed on cell extracts. We will also perform functional studies. Single-cell RNA-Seq in skin biopsies will be performed.
Measured: 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
The overall aim of this WP is to identify how the memory B cell compartment (CD27dull and/or CD27bright memory B cells) are modulated in patients in the initial phase of SSc, therefore only subjects with onset of Raynaud's phenomenon <5 years will be included, plus up 6 controls. We will determine this by flow cytometry and by immunoglobulin sequencing as well as RNA sequencing in patients during the initial phase of the disease with the goal to find prognostic markers during early disease.
Measured: Baseline PBMCs
PBMCs subsets and activation in the pathogenesis of SSc.
We aim to identify specific subsets of PBMCs associated with pathogenesis of SSc, especially T and B lymphocytes.
Measured: Baseline, 2- and 5- years FU
Circulating fibrocytes and pathogenesis of SSc.
Here we aim to study circulating fibrocytes and to identify factors associated with downregulation of the transition of those cells into myofibroblasts.
Measured: Baseline, 2- and 5- years FU
Arthritis involvement in SSc.
The aim of this work package is to assess the burden of articular manifestations in systemic sclerosis (SSc) and to develop a validated articular score.
Measured: Baseline, 2- and 5-years follow up
Assessment of Lung Function and Biomarker Profiling in Patients with Systemic Sclerosis through PExA sampling
Patients with systemic sclerosis from the WESST cohort will be invited to undergo PExA sampling.
Measured: Up to 2 years
Assessment of Lung Function in Patients with Systemic Sclerosis through Insert Gas Washout
Patients with systemic sclerosis will undergo insert gas washout.
Measured: Up to 2 years
Assessment of Lung Function in Patients with Systemic Sclerosis through Impulse Oscillometry
Patients with systemic sclerosis will undergo impulse oscillometry.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start20 Jun 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Zhang, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345052
- Sponsor's protocol ID
- WESST
- Acronym
- WESST
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07345052
- Acronym / sponsor ID
- WESST / WESST
- Conditions
- Scleroderma, Systemic, Fibrosis; Skin, Fibrosis Lung, Interstitial Lung Disease Due to Systemic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: No Intervention: Observational CohortParticipants do not have diagnosis of systemic sclerosis or other rheumatic diseases. |
| Participants with SSc | – | Other: No Intervention: Observational CohortParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Participants diagnosed with SSc according to the ACR and EULAR classification criteria
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational Cohortno intervention | Other | Healthy control, Participants with SSc |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, Systemic and Fibrosis; Skin, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Maglio, MD, PhD (0046 733231485, cristina.maglio@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.