An observational study in Systemic Sclerosis, sponsored by University Hospital, Lille. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University Hospital, Lille · Observational
Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
Browse Scleroderma, Systemic studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
Exclusion Criteria:
Other: Bio-banking without genetic analysis
For patients included in SCLERO-BIOBANK study, 2 blood samples will be collected at each SSc evaluation (usually once a year), in addition to the routine care blood collection.
Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage
Identify biomarkers that are associated with disease prognosis and treatment response during 10 years of follow-up.
Time frame: Through study completion an average of 10 years
EUSTAR score
Identify new biomarkers associated with disease severity and disease activity at study entry and the evolution of disease severity and activity over time
Time frame: Baseline and through study completion, an average of 10 years
Medsger score
Identify new biomarkers associated with disease severity and disease activity at study entry and the evolution of disease severity and activity over time
Time frame: Baseline and through study completion, an average of 10 years
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille