Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

NCT06021262 | Unknown

• 1 other identifier: 0107603
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.What are the prognostic values of neuroinflammatory markers?
2. 2.What are the genotoxic effects of organophosphates?
3. 3.what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

acute exposure group

patients with acute exposure to organophosphates in accidental or suicidal settings

Other: exposure to organophosphates

Interventions

exposure to organophosphates OTHER

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; chronic exposure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pediatric patients.
• Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.)

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Egypt

RECRUITING

Related Publications (9)

• Syed S, Gurcoo SA, Farooqui AK, Nisa W, Sofi K, Wani TM. Is the World Health Organization-recommended dose of pralidoxime effective in the treatment of organophosphorus poisoning? A randomized, double-blinded and placebo-controlled trial. Saudi J Anaesth. 2015 Jan;9(1):49-54. doi: 10.4103/1658-354X.146306.

  PMID: 25558199 BACKGROUND

• Tallat S, Hussien R, Mohamed RH, Abd El Wahab MB, Mahmoud M. Caspases as prognostic markers and mortality predictors in acute organophosphorus poisoning. J Genet Eng Biotechnol. 2020 Apr 13;18(1):10. doi: 10.1186/s43141-020-00024-y.

  PMID: 32281011 BACKGROUND

• Rahimi R, Nikfar S, Abdollahi M. Increased morbidity and mortality in acute human organophosphate-poisoned patients treated by oximes: a meta-analysis of clinical trials. Hum Exp Toxicol. 2006 Mar;25(3):157-62. doi: 10.1191/0960327106ht602oa.

  PMID: 16634335 BACKGROUND

• Caba IC, Streanga V, Dobrin ME, Jitareanu C, Jitareanu A, Profire BS, Apotrosoaei M, Focsa AV, Caba B, Agoroaei L. Clinical Assessment of Acute Organophosphorus Pesticide Poisoning in Pediatric Patients Admitted to the Toxicology Emergency Department. Toxics. 2022 Oct 2;10(10):582. doi: 10.3390/toxics10100582.

  PMID: 36287862 BACKGROUND

• Naughton SX, Terry AV Jr. Neurotoxicity in acute and repeated organophosphate exposure. Toxicology. 2018 Sep 1;408:101-112. doi: 10.1016/j.tox.2018.08.011. Epub 2018 Aug 23.

  PMID: 30144465 BACKGROUND

• Lionetto MG, Caricato R, Calisi A, Giordano ME, Schettino T. Acetylcholinesterase as a biomarker in environmental and occupational medicine: new insights and future perspectives. Biomed Res Int. 2013;2013:321213. doi: 10.1155/2013/321213. Epub 2013 Jul 11.

  PMID: 23936791 BACKGROUND

• Therkorn J, Drewry DG, Tiburzi O, Astatke M, Young C, Rainwater-Lovett K. Review of Biomarkers and Analytical Methods for Organophosphate Pesticides and Applicability to Nerve Agents. Mil Med. 2020 Mar 2;185(3-4):e414-e421. doi: 10.1093/milmed/usz441.

  PMID: 32077949 BACKGROUND

• Kobeissy F, Kobaisi A, Peng W, Barsa C, Goli M, Sibahi A, El Hayek S, Abdelhady S, Ali Haidar M, Sabra M, Oresic M, Logroscino G, Mondello S, Eid AH, Mechref Y. Glycomic and Glycoproteomic Techniques in Neurodegenerative Disorders and Neurotrauma: Towards Personalized Markers. Cells. 2022 Feb 8;11(3):581. doi: 10.3390/cells11030581.

  PMID: 35159390 BACKGROUND

• Salvi RM, Lara DR, Ghisolfi ES, Portela LV, Dias RD, Souza DO. Neuropsychiatric evaluation in subjects chronically exposed to organophosphate pesticides. Toxicol Sci. 2003 Apr;72(2):267-71. doi: 10.1093/toxsci/kfg034.

  PMID: 12660361 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum samples separated from blood samples taken from all study participants.

MeSH Terms

Conditions

Neurotoxicity Syndromes; Nerve Degeneration; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Central Study Contacts

Ahmed F. El Yazbi, professor

CONTACT

01155881772; Ayazbi@aiu.edu.eg

Dina M. El-Gameel, Bachelor of Clinical Pharmacy

CONTACT

01157018176; s-dina.elgameel@alexu.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

EG (1)