Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity

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ClinicalTrials.gov Identifier: NCT06021262

Recruitment Status : Recruiting

First Posted : September 1, 2023

Last Update Posted : September 1, 2023

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Sponsor:

Information provided by (Responsible Party):

Ahmed El-Yazbi, Alexandria University

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

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

Condition or disease	Intervention/treatment
Neuroinflammatory Response Nerve Injury Nerve Damage Neurotoxicity Nerve Degeneration Genotoxicity	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

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Study Type :	Observational
Estimated 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
Estimated Study Start Date :	August 2023
Estimated Primary Completion Date :	December 2023
Estimated Study Completion Date :	January 2024

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease Acute Graft Versus Host Disease Neurotoxicity Syndromes

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	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 :

Identification of neuroinflammatory biomarker [ Time Frame: 1.5 years ]
The biomarker should correlate with nerve injury
Identification of the mechanism of neuroinflammation [ Time Frame: 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.

Biospecimen Retention: Samples With DNA

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
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.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021262

Contacts

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Contact: Ahmed F. El Yazbi, professor	01155881772 ext 002	Ayazbi@aiu.edu.eg
Contact: Dina M. El-Gameel, Bachelor of Clinical Pharmacy	01157018176 ext 002	s-dina.elgameel@alexu.edu.eg

Locations

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Egypt
Alexandria Main University Hospital	Recruiting
Alexandria, Egypt
Contact: Maha A. Ghanem, professor 01223374415 ext 002 ghanemmaha63@gmail.com

Sponsors and Collaborators

Alexandria University

Study Documents (Full-Text)

Documents provided by Ahmed El-Yazbi, Alexandria University:

Study Protocol [PDF] July 30, 2023

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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Responsible Party:	Ahmed El-Yazbi, Professor, Alexandria University
ClinicalTrials.gov Identifier:	NCT06021262
Other Study ID Numbers:	0107603
First Posted:	September 1, 2023 Key Record Dates
Last Update Posted:	September 1, 2023
Last Verified:	August 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Ahmed El-Yazbi, Alexandria University:


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

Additional relevant MeSH terms:

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Nerve Degeneration Organophosphate Poisoning Poisoning Chemically-Induced Disorders Pathologic Processes

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