Prevalence of Hyperprolactinemia in Systemic Scleroderma

Study Overview
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Brief Summary
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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

Official Title
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Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma

Conditions
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Sclerosis, Systemic, Scleroderma, Hyperprolactinemia

Intervention / Treatment
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* Biological: blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scleroderma patients: man or woman over 18 years old with systemic sclerosis meeting ACR-EULAR 2013 criteria having given his no opposition being social insured Healthy subjects: man or woman over 18 years old donation of blood to the EFS matched on age (+/- 5 years) and sex having given his no opposition Exclusion Criteria: Man or woman under 18 years old Pregnant or breastfeeding women Receiving medical treatment inducing dysfunction of the hypothalamic pituitary axis Refusing or unable to give no objection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with systemic sclerosis<br>The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization | Biological: blood test<br>* 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<br>|
| Healthy subjects<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex |  | At 2 years | 
| the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis |  | At 2 years | 
| association between prolactin levels and biological markers of the immune system in scleroderma patients |  | At 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic sclerosis, Scleroderma, Prolactin