Neurotrophins Implications in Primary Sjögren Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)
研究概览
简要总结
Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.
The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.
详细描述
2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.
Salivary sicca syndrome will be evaluated with un-stimulated salivary flow rate. Saliva fluid will be collected from NTs levels determination (ELISA). Ocular sicca syndrome will be evaluated by Schirmer tests and Lissaline green test. A conjunctival cytological impression will be done in order to determine NTs conjunctival production by flow cytometry.
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
- •Arm : primary Sjögren syndrome:
- •All patients must fulfill the revised criteria for primary Sjögren syndrome.
- •Age of entry into the study ≥ 18 yrs.
- •Affiliated or profit patient of a social security system.
- •Informed consent signed up.
- •Arm : healthy volunteers:
- •All patient free of autoimmune disease.
- •Age of entry into the study ≥ 18 yrs.
- •Affiliated or profit patient of a social security system.
- •Informed consent signed up.
排除标准
- •Patient with psychiatric disorders not related with antiphospholipid syndrome and / or cerebral complication of SGSp.
- •Addictive behaviors (alcoholism, cocaine or opioid abuse).
- •Patient with anti-depressive drugs.
- •Patient with concurrent malignancy
- •Pregnancy
- •Patients under measure of maintenance of justice.
- •Patients unable to understand or to participate to the study.
- •Child and major patients making the object of a measure of lawful protection.
- •Patients deprived of freedom.
- •Exclusion criteria for control group
- •Autoimmune disease.
- •Steroid treatment (>20 mg/day).
- •Immunosuppressive treatment.
- •Concurrent malignancy.
- •Concurrent psychiatric disorders.
- •Anti-depressive drugs.
- •Pregnancy.
结局指标
主要结局
Lymphocytic levels of NTs (i.e. NGF, BDNF and NT-3)
时间窗: 1 day
2 supplementary blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up.
次要结局
- Disease activity score used: ESSDAI; NGF, BDNF and NT3 levels in sera; pSS immunological profile; intensity of sicca syndrome; salivary levels of NTs; conjunctival expression of NTs.(1 day)