Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

Study Overview
=================
Brief Summary
-----------------
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 What are the prognostic values of neuroinflammatory markers? What are the genotoxic effects of organophosphates? what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?

Detailed Description
-----------------
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.

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

Conditions
-----------------
Neuroinflammatory Response, Nerve Injury, Nerve Damage, Neurotoxicity, Nerve Degeneration, Genotoxicity

Intervention / Treatment
-----------------
* Other: exposure to organophosphates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Pediatric patients. Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.) Patients who does not meet the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>healthy individuals without previous acute or chronic exposure to organophosphates | |
| chronic exposure group<br>patients with chronic occupational or environmental exposure to organophosphates | Other: exposure to organophosphates<br>* organophosphates are esters of phosphoric acids or Thio phosphoric acids that exist in pesticides, where patients can be chronically or acutely exposed to such compounds.<br>|
| acute exposure group<br>patients with acute exposure to organophosphates in accidental or suicidal settings | Other: exposure to organophosphates<br>* organophosphates are esters of phosphoric acids or Thio phosphoric acids that exist in pesticides, where patients can be chronically or acutely exposed to such compounds.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of neuroinflammatory biomarker | The biomarker should correlate with nerve injury | 1.5 years | 
| Identification of the mechanism of neuroinflammation | 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. | 1.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
organophosphates, neuroinflammatory biomarkers, metabolomic and proteomic analysis, oxidative stress biomarkers, nerve damage, acute and chronic toxicity, neuroinflammation, inflammatory response, pesticides, acetyl choline esterase enzyme inhibition