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Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

A

Alexandria University

Status

Enrolling

Conditions

Nerve Damage
Neuroinflammatory Response
Neurotoxicity
Genotoxicity
Nerve Degeneration
Nerve Injury

Treatments

Other: exposure to organophosphates

Study type

Observational

Funder types

Other

Identifiers

NCT06021262
0107603

Details and patient eligibility

About

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?

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

control group
Description:
healthy individuals without previous acute or chronic exposure to organophosphates
chronic exposure group
Description:
patients with chronic occupational or environmental exposure to organophosphates
Treatment:
Other: exposure to organophosphates
acute exposure group
Description:
patients with acute exposure to organophosphates in accidental or suicidal settings
Treatment:
Other: exposure to organophosphates

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ahmed F. El Yazbi, professor; Dina M. El-Gameel, Bachelor of Clinical Pharmacy

Data sourced from clinicaltrials.gov

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