Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- the prevalence of hyperprolactinemia in scleroderma patients
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients with systemic sclerosis
The study will be systematically offered to any scleroderma patient seen in scheduled hospitalization
干预措施: blood test (Biological)
Healthy subjects
Healthy subjects who will donate blood to the French Blood Establishment (EFS) and matched to scleroderma patients on age (+/- 5 years) and sex
干预措施: blood test (Biological)
结局指标
主要结局
the prevalence of hyperprolactinemia in scleroderma patients
时间窗: 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.
次要结局
- the associations between prolactin levels and clinical (scleroderma phenotype, visceral involvement) and biological (inflammation, antibodies, cytokines) manifestations in systemic sclerosis(At 2 years)
- the prevalence of hyperprolactinemia between scleroderma patients and healthy subjects matched by age and sex(At 2 years)
- association between prolactin levels and biological markers of the immune system in scleroderma patients(At 2 years)