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临床试验/NCT02549248
NCT02549248已完成不适用

Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
NP load

研究概览

简要总结

Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an interstitial lung disease assessed on clinical signs and CT scan, requiring a flexible bronchoscopy with a broncho-alveolar lavage.
  • These patients suffer from:
  • Idiopathic interstitial lung diseases such as idiopathic pulmonary fibrosis or sarcoidosis OR
  • Interstitial lung diseases of known aetiologies such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.
  • Written consent

排除标准

  • Flexible bronchoscopy or BAL not possible.
  • Pregnant women
  • Patients under legal protection.
  • Patients with contagious disease (HIV infection, tuberculosis, viral hepatitis)

结局指标

主要结局

NP load

时间窗: day 1

The load of NP is a composite outcome. It will be described according to their level of presence (high, moderate or low), their size and chemical analysis. Analysis: The presence of NP will be assessed by dynamic light scattering (DLS). The elemental compositions of both the particulate (pellet) and the soluble (supernatant) fractions of each sample will be measured by means of inductively coupled plasma optical emission spectroscopy (ICP-OES). The samples for which DLS and ICP-OES corroborated a relatively stronger NP load will be observed under transmission electron microscopy (TEM) and field-emission electron microscopy (FESEM).

次要结局

  • Correlation between NP load in the lung and observed lung interstitial diseases(Day 1)
  • Correlation between NP load in the lung and NP load in urine specimen(Day 1)
  • Correlation between NP load in the lung and NP load in blood specimen(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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