跳至主要内容
临床试验/NCT06054373
NCT06054373招募中不适用

The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
distribution of immunoglobulin isotypes

研究概览

简要总结

Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients > 18 years old
  • patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma.

排除标准

  • Age < 18 years;
  • chronic viral hepatitis;
  • HIV infection, syphilis,
  • tuberculosis

结局指标

主要结局

distribution of immunoglobulin isotypes

时间窗: one day

distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia associated with autoimmune and systemic diseases (systemic lupus erythematosus, rheumatoid arthritis, Gougerot-Sjögren syndrome, sarcoidosis)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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