Western Sweden Systemic Sclerosis Project
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
This project will collect blood, skin and DNA samples from people with systemic sclerosis in Western Sweden to try to find genes, proteins, and immune changes linked to how the disease starts and gets worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 1 site (Gothenburg, Sweden) |
| Trial ID | NCT07345052 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll a cohort of patients with systemic sclerosis at rheumatology clinics in Gothenburg, Skövde, and Borås. They will collect clinical data and biological samples including blood, skin biopsies, and DNA and apply state-of-the-art molecular and immune profiling. Integrated analyses and in vitro functional studies using patient specimens will be used to identify genes, proteins, metabolites, and immune cell types associated with disease onset and progression. The overall aim is to discover diagnostic or prognostic markers and potential therapeutic targets to inform future care.
Who should consider this trial
Good fit: Adults diagnosed with systemic sclerosis according to ACR/EULAR criteria who can read Swedish and are able to attend participating rheumatology clinics in Western Sweden are ideal candidates.
Not a fit: People with mixed connective tissue disease, those who cannot read Swedish or have severe cognitive impairment, those with disqualifying low blood counts, or those allergic to local anesthetic (if a biopsy is required) would likely be excluded and not benefit from participation.
Why it matters
Potential benefit: If successful, this work could identify markers that enable earlier diagnosis, predict who will develop more aggressive disease, and point to new treatment targets.
How similar studies have performed: Previous cohort and multi-omics studies in systemic sclerosis have reported promising candidate biomarkers and pathways, but no universally validated diagnostic or prognostic markers have yet emerged, so this approach builds on encouraging but still preliminary evidence.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Gothenburg, Sweden
- Rheumatology clinics, Sahlgrenska University Hospital — Gothenburg, Sweden, Sweden (Recruiting)
Study contacts
- Study coordinator: Cristina Maglio, MD, PhD
- Email: cristina.maglio@gu.se
- Phone: 0046 733231485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.