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临床试验/NCT04760197
NCT04760197Unknown不适用

ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis

研究概览

简要总结

New anticancer therapies based on lifting the inhibition of the immunological synapse are used in the therapeutic arsenal of a growing number of neoplasias (melanoma, lung cancer, hepatocellular carcinoma, etc.). These "immune check points" inhibitors "(ICPI) target molecules that usually allow immunity to destroy malignant cells. At the systemic level, this results in a loss of immune homeostasis and facilitation of the inflammatory response which may be responsible for dysimmune manifestations distant from the neoplastic site. Thus, since their introduction, ICPIs have been of interest to immunologists, rheumatologists and internists who often find themselves in the first line to deal with this type of side effect (immunotherapy-related adverse events, IRAEs). The frequency of these ARIs between 70% and 90%, depending on the immunotherapy used and the severity of these ARIIs (grade 1-2 vs. 3-5). The overall increase in the number of cancers, the multiplication of available molecules and the expansion of their indications should exponentially increase the number of IRAEs to be supported. Little is known about the epidemiology, risk factors and efficacy of treatments.

In these IRAEs, inflammatory ophthalmological manifestations have been described with an estimated prevalence of between 0.4 and 1% of the patients treated. These attacks are rare and protean (uveitis, scleritis, retinitis, inflammatory orbitopathies, Vogt-Koyanagi-Harada -like...) and reported most often in the form of clinical cases.

The Main objective is to describe the inflammatory ophthalmic disorders linked to anti-cancer immunotherapy.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • under cancer immunotherapy: anti-PD1 (nivolumab, pembrolizumab), anti-CTLA4 (ipilimumab), anti-PDL1 (atezolizumab, durvalumab, avelumab)
  • diagnosis of uveitis / inflammatory ophthalmologic disease confirmed by at least an ophthalmologist
  • indicating his/her non-opposition to participating in the study

排除标准

  • 未提供

结局指标

主要结局

Clinical evolution of inflammatory ophtalmological manifestation evaluated by gradation of uveitis

时间窗: 6 months after diagnosis

Persistence of disease is characterized by persistence of intraocular inflammation evaluated by gradation of Uveitis according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, November 2017, National Institutes of Health, National Cancer Institute.

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 (2)

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