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临床试验/NCT06021262
NCT06021262招募中不适用

Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

Alexandria University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Identification of neuroinflammatory biomarker

研究概览

简要总结

The aim of this observational study is to answer the following questions in individuals with acute and chronic exposure to organophosphates. The main questions to be addressed are

  1. What are the prognostic values of neuroinflammatory markers?
  2. What are the genotoxic effects of organophosphates?
  3. what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?

详细描述

This is a cross-sectional study that aims to assess the possible prognostic value of markers of neuroinflammation and nerve damage in patients with acute and chronic exposure to organophosphate pesticides by conducting a full proteomic and metabolomic profile. The possible genotoxic effect of common organophosphate pesticides will be studied as well. This will be conducted in parallel to the assessment of traditional markers of inflammation and oxidative stress. The target populations are patients with acute and chronic exposure to organophosphates with a total estimated number of 90 including individuals assigned to the control group with matched age and gender.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

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

  • For the control group: healthy individuals without previous exposure to organophosphates, with the specified age limits.
  • For the acute exposure group: patients with acute exposure to organophosphates, with the specified age limits
  • For the chronic exposure group: patients with chronic exposure to organophosphates, with the specified age limits
  • No restrictions on comorbidities in the three groups except those mentioned under Exclusion Criteria

排除标准

  • Pediatric patients.
  • Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.)
  • Patients who does not meet the inclusion criteria.

结局指标

主要结局

Identification of neuroinflammatory biomarker

时间窗: 1.5 years

The biomarker should correlate with nerve injury

Identification of the mechanism of neuroinflammation

时间窗: 1.5 years

To detect the possible pathways involved in initiation of systemic inflammation rather than inhibition of choline esterase enzyme. As well as, studying the possible relation of these identified mechanisms with neuronal inflammation and damage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed El-Yazbi

Professor

Alexandria University

研究点 (1)

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