Neuroinflammatory ResponseNCT06021262
Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
An observational study of Neuroinflammatory Response and Nerve Injury, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuroinflammatory Response, Nerve Injury, Nerve Damage
- What is being tested?
- exposure to organophosphates
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pediatric patients.
- Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.)
- Patients who does not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Dina M. El-Gameel, Bachelor of Clinical Pharmacy contact
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Main University Hospital
Alexandria
Maha A. Ghanem, professor, 01223374415 ext. 002, ghanemmaha63@gmail.com
About this study
Official title: Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
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?
Read the 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.
- Conditions
- Neuroinflammatory Response, Nerve Injury, Nerve Damage, Neurotoxicity, Nerve Degeneration, Genotoxicity
- Being tested
- exposure to organophosphates
- 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
- Medical subject headings
- Neurotoxicity Syndromes, Nerve Degeneration, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to organophosphatesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | healthy individuals without previous acute or chronic exposure to organophosphates | |
| chronic exposure group | patients with chronic occupational or environmental exposure to organophosphates Receives: Other: exposure to organophosphates | |
| acute exposure group | patients with acute exposure to organophosphates in accidental or suicidal settings Receives: Other: exposure to organophosphates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of neuroinflammatory biomarker
The biomarker should correlate with nerve injury
Measured: 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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neuroinflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Yazbi, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021262
- Sponsor's protocol ID
- 0107603
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25558199Tallat 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.
PubMed 32281011Rahimi 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.
PubMed 16634335Caba 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.
PubMed 36287862Naughton 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.
PubMed 30144465Lionetto 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.
PubMed 23936791Therkorn 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.
PubMed 32077949Kobeissy 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.
PubMed 35159390Salvi 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.
PubMed 12660361
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
- ClinicalTrials.gov ID
- NCT06021262
- Acronym / sponsor ID
- 0107603
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | –healthy individuals without previous acute or chronic exposure to organophosphates |
| chronic exposure group | – | Other: exposure to organophosphatespatients with chronic occupational or environmental exposure to organophosphates |
| acute exposure group | – | Other: exposure to organophosphatespatients with acute exposure to organophosphates in accidental or suicidal settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pediatric patients.
- Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.)
- Patients who does not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to organophosphatesorganophosphates are esters of phosphoric acids or Thio phosphoric acids that exist in pesticides, where patients can be chronically or acutely exposed to such compounds. | Other | acute exposure group, chronic exposure group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 25558199Syed 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.
- Background: PubMed 32281011Tallat 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.
- Background: PubMed 16634335Rahimi 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.
- Background: PubMed 36287862Caba 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.
- Background: PubMed 30144465Naughton 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.
- Background: PubMed 23936791Lionetto 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.
- Background: PubMed 32077949Therkorn 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.
- Background: PubMed 35159390Kobeissy 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.
- Background: PubMed 12660361Salvi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina M. El-Gameel, Bachelor of Clinical Pharmacy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroinflammatory Response and Nerve Injury, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed F. El Yazbi, professor (01155881772 ext. 002, Ayazbi@aiu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of neuroinflammatory biomarker (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06021262, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.