Hyperprolactinemia, Scleroderma, Sclerosis, Systemic
Conditions
Keywords
Systemic sclerosis, Scleroderma, Prolactin
Brief summary
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
Interventions
BIOLOGICALblood 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
Sponsors
Association pour la Formation et la Recherche en Médecine Interne (AFORMI)
University Hospital, Lille
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the prevalence of hyperprolactinemia in scleroderma patients | At 2 years | 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. |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed