Systemic Lupus Erythematosus and Accelerated Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Absolute numbers of naïve T lymphocytes
研究概览
简要总结
The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.
详细描述
Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a breakdown of tolerance against nuclear antigens. Thanks to improvements during the last decades in diagnosis, therapeutics and medical care, the lifespan of SLE patients has remarkably increased. However, standardized mortality ratio are still high in this population, with an increased mortality and morbidity associated with cardiovascular events and infectious events. Interestingly, these conditions are more commonly found during old age in the general population, raising the question of the presence of an acceleration of the aging process in SLE patients.
It has been demonstrated that the aging of the immune system, i.e. immunosenescence, is a key player in the development of many age-related diseases. The acceleration of immunosenescence, as it is observed during chronic viral infections for example, could favor the premature occurrence of clinical manifestations of accelerated aging. The exact contribution of such phenomenon in the context of SLE has, so far, never been explored.
Here, the investigators propose to perform a comprehensive study of the phenomena of immune system aging in patients with SLE in comparison to age-matched healthy controls.
The study will recruit 50 SLE patients followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to extensively evaluate immune system aging. Fundamental research will be realized on patients' samples. Patients will be included within their usual follow-up. No extra visit will be needed, and blood samples will be drawn at the same time as those drawn for clinical purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female;
- •age between 18 and 60 years;
- •Lupus patient : diagnosis of systemic lupus erythematosus according to ACR or SLICC criteria;
- •being affiliated to health insurance;
- •willing to participate and to sign informed consent.
排除标准
- •pregnant or breastfeeding women;
- •persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent
研究组 & 干预措施
Systemic Lupus Erythematosus
Diagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria
干预措施: blood sample (Biological)
Controls
Healthy controls
干预措施: blood sample (Biological)
结局指标
主要结局
Absolute numbers of naïve T lymphocytes
时间窗: At baseline (Day 0)
次要结局
- Presence or absence of anti-type I interferons autoantibodies in patients sera(At baseline (Day 0))
- Absolute numbers of terminally differentiated T lymphocytes(At baseline (Day 0))
- Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)(At baseline (Day 0))
- Levels of anti-double stranded DNA in patients sera(At baseline (Day 0))
- Percentages of senescent lymphocytes among total lymphocytes(At baseline (Day 0))
- Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement(At baseline (Day 0))
- Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera(At baseline (Day 0))
- Levels of complement components C3 and C4 in patients sera(At baseline (Day 0))
- Percentages of terminally differentiated T lymphocytes among total lymphocytes(At baseline (Day 0))
- Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming(At baseline (Day 0))
- Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)(At baseline (Day 0))
- Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)(At baseline (Day 0))
- Quantification of organ damage according to SLICC/ACR Damage Index(At baseline (Day 0))