Clinical trial NCT06021262: Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
Official title: Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroinflammatory Response
Nerve Injury
Nerve Damage
Neurotoxicity
Nerve Degeneration
Genotoxicity
Keywords: 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
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Acute exposure patients will be recruited from the Poison Center and Emergency Department of Alexandria Main University Hospital.
* Chronic exposure patients will be recruited from farm field workers with a confirmed history of repeated occupational exposure to organophosphate pesticides.
* Control subjects will be recruited from city dwellers without any medical conditions (healthy subjects) with comparable age and gender.

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.

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.

Primary outcomes:
measure: Identification of neuroinflammatory biomarker
timeFrame: 1.5 years
measure: Identification of the mechanism of neuroinflammation
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospital
Study officials:
References:
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