Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06021262
Collaborator
(none)
90
1
5
17.9

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: exposure to organophosphates

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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
control group

healthy individuals without previous acute or chronic exposure to organophosphates

chronic exposure group

patients with chronic occupational or environmental exposure to organophosphates

Other: exposure to organophosphates
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.

acute exposure group

patients with acute exposure to organophosphates in accidental or suicidal settings

Other: exposure to organophosphates
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.

Outcome Measures

Primary Outcome Measures

  1. Identification of neuroinflammatory biomarker [1.5 years]

    The biomarker should correlate with nerve injury

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria Main University Hospital Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Ahmed El-Yazbi, Professor, Alexandria University
ClinicalTrials.gov Identifier:
NCT06021262
Other Study ID Numbers:
  • 0107603
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed El-Yazbi, Professor, Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2023