Prevalence of Hyperprolactinemia in Systemic Scleroderma

University Hospital, Lille71 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sclerosis, Systemic Scleroderma Hyperprolactinemia

Interventions

blood testBIOLOGICAL

* 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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hop Claude Huriez Chu Lille

Lille, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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