An observational study in Sclerosis, Systemic, Scleroderma and Hyperprolactinemia, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Observational
Systemic sclerosis is an autoimmune and inflammatory disease characterized primarily by fibrosis and vascular involvement. We know that the immune system is disrupted in systemic sclerosis, but there are probably other mechanisms to explain the disease, including deregulation of certain proteins such as prolactin
Scleroderma patients are from scheduled hospitalization Department of Internal Medicine and Clinical Immunology, CHU Lille Healthy subjects are from the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex
Scleroderma patients:
Healthy subjects:
Exclusion Criteria:
The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization
Biological: blood test
Healthy subjects who will donate blood to the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex
Biological: blood test
* to analysis prolactin in healthy subjects and scleroderma patients * then to analysis in only scleroderma patients: thyroid-stimulating hormone (TSH), thyroxine (T4), luteinizing hormone (LH), oestradiol, follicle-stimulating hormone (FSH), BAFF (B-cell activating factor), IL-6 (interleukin 6) and endoglin
the prevalence of hyperprolactinemia in scleroderma patients
Rate of prolactin measured by immuno-chemiluminescence (Abbott Architect automaton). The presence of a defined hyperprolactinemia at the University Hospital of Lille: for women, prolactin level higher than 26.5 ng/mL and for men, higher than 19.4 ng/mL.
Time frame: At 2 years
the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex
Time frame: At 2 years
the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis
Time frame: At 2 years
association between prolactin levels and biological markers of the immune system in scleroderma patients
Time frame: At 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille