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临床试验/NCT02158208
NCT02158208已完成不适用

Study of the T CD8 Immune Response in Horton's Disease

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)

研究概览

简要总结

The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.

At the inclusion visit, patients will have, as is the case in the usual strategy:

  • A complete clinical examination carried out by the doctor in charge of the patient
  • ESR, and CRP and fibrinogen assay
  • A full blood count for leukocytes and lymphocytes
  • A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.

In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:

  • Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations.
  • A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
  • 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients who have provided written informed consent
  • Patients covered by national health insurance
  • Age > 50 years
  • Patients with Horton's disease at the diagnosis before any treatment
  • Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated:
  • age at the onset of the disease 50 years or above
  • recent onset localised headache
  • indurated temporal artery or decrease/absence of temporal pulse
  • erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP>20 mg/L)
  • positive TAB showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells.
  • Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (CRP<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be matched for age and sex.
  • Age > 50 years
  • Patients covered by national health insurance
  • who have provided written informed consent to take part
  • Absence of inflammatory syndrome (CRP<5 mg /L)

排除标准

  • Any patient not meeting inclusion criteria
  • Patient treated with corticoids or immunosuppressants in the month preceding inclusion
  • Patients treated with chemotherapy

研究组 & 干预措施

Patients with HD

干预措施: Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment (Other)

Patients with HD

干预措施: 16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment (Other)

Controls

干预措施: Blood sample drawn into a 5 mL dry tube (Other)

Controls

干预措施: 16 blood samples drawn into 6 mL heparinized tubes (Other)

结局指标

主要结局

The percentage of cytotoxic T lymphocytes CD8 (CD8+perforin+granzyme B+)

时间窗: Change from baselines the percentage of cytotoxic T lymphocytes CD8 at 3 months of treatment

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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