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/NCT05963295</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-16MS</org_study_id>
      <nct_id>NCT05963295</nct_id>
    </id_info>
    <brief_title>Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies</brief_title>
    <official_title>Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        Toxoplasmosis is one of the most common zoonotic diseases caused by the obligate&#xD;
        intracellular parasite, T. gondii. It affects up to one-third of the world's population&#xD;
        Horizontal transmission is mostly caused by ingestion of tissue cysts in infected meat, or&#xD;
        through consumption of food or drink contaminated with sporulated oocysts, while vertical&#xD;
        transmission occurs due to primary acquired maternal infection throughout pregnancy.In&#xD;
        immunocompetent hosts, acquired infection is asymptomatic in more than 80% of cases, or is&#xD;
        associated with fever,cervical lymphadenopathy, or myalgia.&#xD;
  &#xD;
        In immunocompromised patients,toxoplasmosis is always life-threatening where toxoplasmic&#xD;
        encephalitis is the most important presentation. Among those patients, the disease may be&#xD;
        caused by a newly acquired infection, reactivation following cyst rupture, donation of a&#xD;
        cyst-containing organ from a seropositive donor to a seronegative recipient, or reactivation&#xD;
        of dormant infection in the recipient Patients with hematological malignancy (HM), including&#xD;
        those with acute myelogenous leukemia, and those who have undergone hematopoietic stem cell&#xD;
        transplantation or treated with aggressive immunosuppressive regimens are at high risk of&#xD;
        opportunistic infections The association between toxoplasmosis and cancers remains dual. Most&#xD;
        cancer patients are in a state of impaired cellular and humoral immune systems either from&#xD;
        the primary disease, or from chemotherapy and/or radiotherapy administration.&#xD;
        Chemotherapeutic drugs work by killing both fast growing cancer cells, and healthy white&#xD;
        blood cells causing neutropenia. So, patients receiving chemotherapy are more susceptible to&#xD;
        Toxoplasma infections.&#xD;
  &#xD;
        Many studies have reported that the rate of reactivation of a latent T. gondii infection was&#xD;
        higher in different types of cancers particularly those of the eye, brain, blood and breast.&#xD;
        On the other side, T. gondii was also implicated as possible oncogenic pathogen with&#xD;
        suggested role in induction and progression of malignant diseases. This was explained by many&#xD;
        theories such as preventing apoptosis, enhancing the motility of dendritic cells and&#xD;
        macrophages.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>toxoplasma IgG</measure>
      <time_frame>1 year</time_frame>
      <description>rising titre</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Toxoplasmosis</condition>
    <arm_group>
      <arm_group_label>patient with hematlolgical malignancies</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>toxoplasma igG</intervention_name>
      <description>Dignosis of toxoplasma</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>patient with hematlolgical malignancies</arm_group_label>
      <other_name>toxoplasma IgM</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  This study will be conducted on a group of patients who are diagnosed as have&#xD;
               hematological malignancies&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with other non hematological malignancies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>nourhan m abd elhaliem, resident</last_name>
      <phone>01096779396</phone>
      <email>norhanmohamed@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmed a allam, assistant professor</last_name>
      <phone>01001636593</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Magdy M Amin, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Elzeny H, Mohamed W, Daef E, El-Badawy O, Shaaban L, Osman NS, Hadiya S, Aly S. Detection of multiple extensively-drug resistant hypervirulent Klebsiella pneumoniae clones from patients with ventilator-associated pneumonia in Egypt. J Med Microbiol. 2023 Jun;72(6). doi: 10.1099/jmm.0.001701.</citation>
      <PMID>37288576</PMID>
    </reference>
    <reference>
      <citation>Dupont D, Fricker-Hidalgo H, Brenier-Pinchart MP, Garnaud C, Wallon M, Pelloux H. Serology for Toxoplasma in Immunocompromised Patients: Still Useful? Trends Parasitol. 2021 Mar;37(3):205-213. doi: 10.1016/j.pt.2020.09.006. Epub 2020 Oct 9.</citation>
      <PMID>33046380</PMID>
    </reference>
    <reference>
      <citation>Anvari D, Sharif M, Sarvi S, Aghayan SA, Gholami S, Pagheh AS, Hosseini SA, Saberi R, Chegeni TN, Hosseininejad Z, Daryani A. Seroprevalence of Toxoplasma gondii infection in cancer patients: A systematic review and meta-analysis. Microb Pathog. 2019 Apr;129:30-42. doi: 10.1016/j.micpath.2019.01.040. Epub 2019 Jan 29.</citation>
      <PMID>30708042</PMID>
    </reference>
    <reference>
      <citation>Kalantari N, Gorgani-Firouzjaee T, Hassani S, Chehrazi M, Ghaffari S. Association between Toxoplasma gondii exposure and hematological malignancies: A systematic review and meta-analysis. Microb Pathog. 2020 Nov;148:104440. doi: 10.1016/j.micpath.2020.104440. Epub 2020 Aug 19.</citation>
      <PMID>32822769</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Norhan Mohamed Abdelhalim</investigator_full_name>
      <investigator_title>resident-clinical pathology sohag university hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Toxoplasmosis</mesh_term>
      <mesh_term>Hematologic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05963295
  org study id: Soh-Med-23-07-16MS
  nct id: NCT05963295
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Toxoplasmosis is one of the most common zoonotic diseases caused by the obligate
        intracellular parasite, T. gondii. It affects up to one-third of the world's population
        Horizontal transmission is mostly caused by ingestion of tissue cysts in infected meat, or
        through consumption of food or drink contaminated with sporulated oocysts, while vertical
        transmission occurs due to primary acquired maternal infection throughout pregnancy.In
        immunocompetent hosts, acquired infection is asymptomatic in more than 80% of cases, or is
        associated with fever,cervical lymphadenopathy, or myalgia.
  
        In immunocompromised patients,toxoplasmosis is always life-threatening where toxoplasmic
        encephalitis is the most important presentation. Among those patients, the disease may be
        caused by a newly acquired infection, reactivation following cyst rupture, donation of a
        cyst-containing organ from a seropositive donor to a seronegative recipient, or reactivation
        of dormant infection in the recipient Patients with hematological malignancy (HM), including
        those with acute myelogenous leukemia, and those who have undergone hematopoietic stem cell
        transplantation or treated with aggressive immunosuppressive regimens are at high risk of
        opportunistic infections The association between toxoplasmosis and cancers remains dual. Most
        cancer patients are in a state of impaired cellular and humoral immune systems either from
        the primary disease, or from chemotherapy and/or radiotherapy administration.
        Chemotherapeutic drugs work by killing both fast growing cancer cells, and healthy white
        blood cells causing neutropenia. So, patients receiving chemotherapy are more susceptible to
        Toxoplasma infections.
  
        Many studies have reported that the rate of reactivation of a latent T. gondii infection was
        higher in different types of cancers particularly those of the eye, brain, blood and breast.
        On the other side, T. gondii was also implicated as possible oncogenic pathogen with
        suggested role in induction and progression of malignant diseases. This was explained by many
        theories such as preventing apoptosis, enhancing the motility of dendritic cells and
        macrophages.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: toxoplasma IgG
  time frame: 1 year
  description: rising titre
  arm group label: patient with hematlolgical malignancies
  arm group type: Active Comparator
  arm group label: control group
  arm group type: Active Comparator
  intervention type: Diagnostic Test
  intervention name: toxoplasma igG
  description: Dignosis of toxoplasma
  arm group label: control group
  arm group label: patient with hematlolgical malignancies
  other name: toxoplasma IgM
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: nourhan m abd elhaliem, resident
  phone: 01096779396
  email: norhanmohamed@med.sohag.edu.eg
  last name: Ahmed a allam, assistant professor
  phone: 01001636593
  facility: 
  contact: 
  country: Egypt
  citation: Elzeny H, Mohamed W, Daef E, El-Badawy O, Shaaban L, Osman NS, Hadiya S, Aly S. Detection of multiple extensively-drug resistant hypervirulent Klebsiella pneumoniae clones from patients with ventilator-associated pneumonia in Egypt. J Med Microbiol. 2023 Jun;72(6). doi: 10.1099/jmm.0.001701.
  PMID: 37288576
  citation: Dupont D, Fricker-Hidalgo H, Brenier-Pinchart MP, Garnaud C, Wallon M, Pelloux H. Serology for Toxoplasma in Immunocompromised Patients: Still Useful? Trends Parasitol. 2021 Mar;37(3):205-213. doi: 10.1016/j.pt.2020.09.006. Epub 2020 Oct 9.
  PMID: 33046380
  citation: Anvari D, Sharif M, Sarvi S, Aghayan SA, Gholami S, Pagheh AS, Hosseini SA, Saberi R, Chegeni TN, Hosseininejad Z, Daryani A. Seroprevalence of Toxoplasma gondii infection in cancer patients: A systematic review and meta-analysis. Microb Pathog. 2019 Apr;129:30-42. doi: 10.1016/j.micpath.2019.01.040. Epub 2019 Jan 29.
  PMID: 30708042
  citation: Kalantari N, Gorgani-Firouzjaee T, Hassani S, Chehrazi M, Ghaffari S. Association between Toxoplasma gondii exposure and hematological malignancies: A systematic review and meta-analysis. Microb Pathog. 2020 Nov;148:104440. doi: 10.1016/j.micpath.2020.104440. Epub 2020 Aug 19.
  PMID: 32822769
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Norhan Mohamed Abdelhalim
  investigator title: resident-clinical pathology sohag university hospital
  mesh term: Toxoplasmosis
  mesh term: Hematologic Neoplasms
  sharing ipd: Undecided