xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021262</url>
    </required_header>
    <id_info>
      <org_study_id>0107603</org_study_id>
      <nct_id>NCT06021262</nct_id>
    </id_info>
    <brief_title>Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity</brief_title>
    <official_title>Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this observational study is to answer the following questions in individuals with&#xD;
        acute and chronic exposure to organophosphates. The main questions to be addressed are&#xD;
  &#xD;
          1. What are the prognostic values of neuroinflammatory markers?&#xD;
  &#xD;
          2. What are the genotoxic effects of organophosphates?&#xD;
  &#xD;
          3. what are the changes occurring in the levels of traditional oxidative stress and&#xD;
             inflammatory markers?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a cross-sectional study that aims to assess the possible prognostic value of markers&#xD;
        of neuroinflammation and nerve damage in patients with acute and chronic exposure to&#xD;
        organophosphate pesticides by conducting a full proteomic and metabolomic profile. The&#xD;
        possible genotoxic effect of common organophosphate pesticides will be studied as well. This&#xD;
        will be conducted in parallel to the assessment of traditional markers of inflammation and&#xD;
        oxidative stress. The target populations are patients with acute and chronic exposure to&#xD;
        organophosphates with a total estimated number of 90 including individuals assigned to the&#xD;
        control group with matched age and gender.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Identification of neuroinflammatory biomarker</measure>
      <time_frame>1.5 years</time_frame>
      <description>The biomarker should correlate with nerve injury</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Identification of the mechanism of neuroinflammation</measure>
      <time_frame>1.5 years</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Neuroinflammatory Response</condition>
    <condition>Nerve Injury</condition>
    <condition>Nerve Damage</condition>
    <condition>Neurotoxicity</condition>
    <condition>Nerve Degeneration</condition>
    <condition>Genotoxicity</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>healthy individuals without previous acute or chronic exposure to organophosphates</description>
    </arm_group>
    <arm_group>
      <arm_group_label>chronic exposure group</arm_group_label>
      <description>patients with chronic occupational or environmental exposure to organophosphates</description>
    </arm_group>
    <arm_group>
      <arm_group_label>acute exposure group</arm_group_label>
      <description>patients with acute exposure to organophosphates in accidental or suicidal settings</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exposure to organophosphates</intervention_name>
      <description>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.</description>
      <arm_group_label>acute exposure group</arm_group_label>
      <arm_group_label>chronic exposure group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        serum samples separated from blood samples taken from all study participants.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          -  Acute exposure patients will be recruited from the Poison Center and Emergency&#xD;
               Department of Alexandria Main University Hospital.&#xD;
  &#xD;
            -  Chronic exposure patients will be recruited from farm field workers with a confirmed&#xD;
               history of repeated occupational exposure to organophosphate pesticides.&#xD;
  &#xD;
            -  Control subjects will be recruited from city dwellers without any medical conditions&#xD;
               (healthy subjects) with comparable age and gender.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For the control group: healthy individuals without previous exposure to&#xD;
               organophosphates, with the specified age limits.&#xD;
  &#xD;
            -  For the acute exposure group: patients with acute exposure to organophosphates, with&#xD;
               the specified age limits&#xD;
  &#xD;
            -  For the chronic exposure group: patients with chronic exposure to organophosphates,&#xD;
               with the specified age limits&#xD;
  &#xD;
          No restrictions on comorbidities in the three groups except those mentioned under Exclusion&#xD;
          Criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pediatric patients.&#xD;
  &#xD;
            -  Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease,&#xD;
               etc.)&#xD;
  &#xD;
            -  Patients who does not meet the inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ahmed F. El Yazbi, professor</last_name>
      <phone>01155881772</phone>
      <phone_ext>002</phone_ext>
      <email>Ayazbi@aiu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dina M. El-Gameel, Bachelor of Clinical Pharmacy</last_name>
      <phone>01157018176</phone>
      <phone_ext>002</phone_ext>
      <email>s-dina.elgameel@alexu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Alexandria Main University Hospital</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maha A. Ghanem, professor</last_name>
        <phone>01223374415</phone>
        <phone_ext>002</phone_ext>
        <email>ghanemmaha63@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>25558199</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32281011</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>16634335</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>36287862</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30144465</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>23936791</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32077949</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35159390</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>12660361</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Ahmed El-Yazbi</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>organophosphates</keyword>
    <keyword>neuroinflammatory biomarkers</keyword>
    <keyword>metabolomic and proteomic analysis</keyword>
    <keyword>oxidative stress biomarkers</keyword>
    <keyword>nerve damage</keyword>
    <keyword>acute and chronic toxicity</keyword>
    <keyword>neuroinflammation</keyword>
    <keyword>inflammatory response</keyword>
    <keyword>pesticides</keyword>
    <keyword>acetyl choline esterase enzyme inhibition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nerve Degeneration</mesh_term>
      <mesh_term>Organophosphate Poisoning</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 30, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT06021262/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021262
  org study id: 0107603
  nct id: NCT06021262
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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?
  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.
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: Identification of neuroinflammatory biomarker
  time frame: 1.5 years
  description: The biomarker should correlate with nerve injury
  measure: Identification of the mechanism of neuroinflammation
  time frame: 1.5 years
  description: 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.
  arm group label: control group
  description: healthy individuals without previous acute or chronic exposure to organophosphates
  arm group label: chronic exposure group
  description: patients with chronic occupational or environmental exposure to organophosphates
  arm group label: acute exposure group
  description: patients with acute exposure to organophosphates in accidental or suicidal settings
  intervention type: Other
  intervention name: exposure to organophosphates
  description: 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.
  arm group label: acute exposure group
  arm group label: chronic exposure group
  serum samples separated from blood samples taken from all study participants.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed F. El Yazbi, professor
  phone: 01155881772
  phone ext: 002
  email: Ayazbi@aiu.edu.eg
  last name: Dina M. El-Gameel, Bachelor of Clinical Pharmacy
  phone: 01157018176
  phone ext: 002
  email: s-dina.elgameel@alexu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Ahmed El-Yazbi
  investigator title: Professor
  mesh term: Nerve Degeneration
  mesh term: Organophosphate Poisoning
  provided document: 