Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

Recruiting

• Conditions: Nerve Injury; Nerve Degeneration; Neuroinflammatory Response; Neurotoxicity; Nerve Damage; Genotoxicity
• Interventions: Other: exposure to organophosphates

• Registration Number: NCT06021262
• Lead Sponsor: Alexandria University

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

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?

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.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08
• Study First Submitted: 2023-08-27
• Study First Submitted QC: 2023-08-27
• Last Update Submitted: 2023-08-27
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic exposure group	exposure to organophosphates	patients with chronic occupational or environmental exposure to organophosphates
acute exposure group	exposure to organophosphates	patients with acute exposure to organophosphates in accidental or suicidal settings

Primary Outcome Measures

Name	Time	Method
Identification of neuroinflammatory biomarker	1.5 years	The biomarker should correlate with nerve injury
Identification of the mechanism of neuroinflammation	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.

Trial Locations

Locations (1)

Alexandria Main University Hospital; 🇪🇬 Alexandria, Egypt