跳至主要内容
临床试验/NCT03346018
NCT03346018已完成不适用

Observational Study: Definition of Immunologic Markers for the Differential Diagnosis Between Uveitis From Supposed Tuberculous Etiology and Sarcoidosis Uveitis

Azienda USL Reggio Emilia - IRCCS1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2017年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Identify, in the aqueous humor and in the blood of patients suffering from granulomatous uveitis the presence of immunologic markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis

研究概览

简要总结

Today there are no tests that allow to make a precise differential diagnosis between uveitis from presumed tuberculous origin and uveitis by sarcoidosis. Therefore, with this study, investigators aim to identify, in the aqueous humor and in the blood of participants (patients that suffering from one of these two forms of uveitis) the presence of immunologic markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis.

详细描述

Both tuberculosis and sarcoidosis are chronic, multi-systemic and granulomatous pathologies that have very similar pulmonary and extra-pulmonary manifestations, and even in the case of ocular involvement it has been shown that many features of intraocular TB can also be found in participants with ocular sarcoidosis.

In this monocentric observational study investigators are asking to the participants with granulomatous uveitis, in which a tuberculosis or sarcoidosis origin is suspected and who will have undergo paracentesis of the anterior chamber, to grant part of the aqueous humor and a blood sample for this study.

The collected samples will be analyzed as follow:

  1. Determination of the concentration of various cytokines, chemokines and growth factors in aqueous humor and in the plasma.
  2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ (CD3 is the acronym of cluster of differentiation 3: a glycoprotein found on the surface of immune cells) and CD4+ ((CD4 is the acronym of cluster of differentiation 4), T cytotoxic lymphocytes CD3+ CD8+ (CD8 is the acronym of cluster of differentiation 8) , B lymphocytes CD19+ (CD19 is the acronym of cluster of differentiation 19), Natural killer lymphocytes CD56+ (CD56 is the acronym of cluster of differentiation 56) and CD3- and monocytes CD14+ (CD14 is the acronym of cluster of differentiation 14) present in the aqueous humor by cytofluorimetry.
  3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
  4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells in aqueous humor with epitopes of tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diagnosis of uveitis of tuberculous etiology or patients with diagnosis of uveitis of suspect sarcoidosis or patients with diagnosis of uveitis of undifferentiated origin (tuberculosis/sarcoidosis)

排除标准

  • Patients suffering from non-granulomatous uveitis.

结局指标

主要结局

Identify, in the aqueous humor and in the blood of patients suffering from granulomatous uveitis the presence of immunologic markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis

时间窗: 3 days

The statistical analysis will based on the use of non parametric test between Group (Mann Whitney)

次要结局

未报告次要终点

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验