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临床试验/NCT05528809
NCT05528809已完成不适用

Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Circulating epithelial cell detection rate

研究概览

简要总结

Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.

详细描述

Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities.

The criteria for classification of the disease include dry syndrome, positive salivary gland biopsy and detection of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and anti-Sjögren's-syndrome-related antigen B (anti-SSB) antibodies. The presence of antibodies is thus important for the diagnosis but not essential, because in some patients the salivary gland biopsy is positive and the antibodies are absent. Therefore, the identification of new biomarkers could be very useful to confirm the diagnosis of primary Gougerot-Sjögren's syndrome and to identify subgroups of patients.

The pathophysiology of the disease remains largely unknown. Currently, primary Gougerot-Sjögren's syndrome is thought to originate from inflammation of the epithelial tissue of the salivary glands. However, it is currently unknown whether this autoimmune epithelitis is accompanied by a contingent of circulating epithelial cells, the characterization of which might be accessible by liquid biopsy.

So far, the circulating epithelial cells that have been identified have been identified in the context of cancer: in this case they are called circulating tumor cells. Their detection during primary Gougerot-Sjögren's syndrome could reflect the intensity of epithelial aggression, and thus possibly constitute a biomarker.

In other connectivities, data on circulating cells have already been published. In systemic scleroderma, another connectivitis affecting mainly middle-aged women, circulating progenitor cells have already been detected and are thought to have the capacity to differentiate into endothelial cells, thus playing a potentially important role in the pathophysiology of the disease.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients over the age of 18
  • Written and signed consent by the participant and the investigator
  • Affiliated person or beneficiary of the social security system
  • Test group: patients with Gougerot-Sjögren's syndrome connectivitis meeting the ACR/EULAR classification criteria
  • Positive control group: patients with diffuse systemic scleroderma connectivitis meeting ACR/EULAR classification criteria

排除标准

  • Association of the two diseases in the same patient
  • Progressive cancer
  • Subject protected by law, under guardianship or curatorship
  • Inability to give free and informed consent to participate in the study
  • Withdrawal of consent

结局指标

主要结局

Circulating epithelial cell detection rate

时间窗: day 0

Rate of patients with at least 1 circulating epithelial cell in the peripheral blood

次要结局

  • Number of circulating epithelial and endothelial cells(day 0)
  • Number of circulating epithelial cells(day 0)
  • Number of circulating epithelial cells expressing human epidermal growth factor receptor 2 (HER2)(day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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