<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/NCT04404244</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU P25a/ 2020</org_study_id>
    <nct_id>NCT04404244</nct_id>
  </id_info>
  <brief_title>Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic</brief_title>
  <acronym>PedCan-COVID</acronym>
  <official_title>Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatma Soliman Elsayed Ebeid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a prospective follow-up non-intervention study that will be carried out at&#xD;
      Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All&#xD;
      followed-up children below 18 years with cancer during the one year study period from May&#xD;
      2020 till Apr 2021 either at the out-patients clinic or inpatient department will be&#xD;
      recruited.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Procedures:&#xD;
&#xD;
      On admission or during the outpatient visit:&#xD;
&#xD;
        1. Obtaining an informed consent .&#xD;
&#xD;
        2. Full medical history, concurrent medications, demographic data and epidemiological data&#xD;
           (history of contact to a COVID-19 case, history of travel), will be obtained.&#xD;
&#xD;
        3. A thorough physical examination will be performed.&#xD;
&#xD;
        4. Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and&#xD;
           blood oxygen saturation) will be recorded.&#xD;
&#xD;
        5. Laboratory to perform the following tests:&#xD;
&#xD;
      Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase&#xD;
      Chain Reaction (RT-PCR) test by nasopharyngeal swab.&#xD;
&#xD;
      During admission:&#xD;
&#xD;
      Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19&#xD;
      suspected to have the following to be performed:&#xD;
&#xD;
        1. Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if&#xD;
           indicated will be collected&#xD;
&#xD;
        2. Chest X-ray or CT chest will be recorded.&#xD;
&#xD;
        3. Laboratory to perform the following tests:&#xD;
&#xD;
      Complete blood count with differential counts,&#xD;
&#xD;
      COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:&#xD;
&#xD;
      C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and&#xD;
      INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures&#xD;
      will be recorded&#xD;
&#xD;
      On discharge:&#xD;
&#xD;
        -  Date of discharge&#xD;
&#xD;
        -  Period of admission&#xD;
&#xD;
        -  Period of fever&#xD;
&#xD;
        -  A thorough physical examination will be performed&#xD;
&#xD;
        -  Record the outcome&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of COVID-19 among children with cancer</measure>
    <time_frame>12 months</time_frame>
    <description>Measure the incidence of COVID-19 infection among children with cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Families training</measure>
    <time_frame>12 months</time_frame>
    <description>Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Coronavirus COVID-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All followed-up children below 18 years with with malignancy either hematological or solid&#xD;
        tumors or hematological condition during the one year study period from May 2020 till Apr&#xD;
        2021 either at the out-patients clinic or inpatient department will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children below 18 years with malignancy either hematological or solid tumors or&#xD;
&#xD;
          2. Children below 18 years with hematological condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients or care-givers refusal to be enrolled in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatma Ebeid</last_name>
    <role>Principal Investigator</role>
    <affiliation>Excuitive Director of MARSI-CRC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fatma Ebeid</last_name>
    <phone>+201095569596</phone>
    <email>dr.fatma_ebeid@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center</name>
      <address>
        <city>Cairo</city>
        <state>Non-US</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatma Soliman E Ebeid</last_name>
      <phone>01095569596</phone>
      <email>dr.fatma_ebeid@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Ebeid FSE, Ragab IA, Elsherif NHK, Makkeyah S, Mostafa S, Eltonbary K, Matbouly S, Mostafa A, Goma H, Agwa SH, Hafez HM, Girgis S, El Gendy YG, El-Sayed MH. COVID-19 in Children With Cancer: A Single Low-Middle Income Center Experience. J Pediatr Hematol Oncol. 2021 Nov 1;43(8):e1077-e1081. doi: 10.1097/MPH.0000000000002025.</citation>
    <PMID>33290293</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>April 17, 2021</last_update_submitted>
  <last_update_submitted_qc>April 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Fatma Soliman Elsayed Ebeid</investigator_full_name>
    <investigator_title>Executive Director of Faculty of Medicine Ain Shams University Research Institute - Clinical Research Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04404244
org study id: FMASU P25a/ 2020
nct id: NCT04404244
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective follow-up non-intervention study that will be carried out at
      Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All
      followed-up children below 18 years with cancer during the one year study period from May
      2020 till Apr 2021 either at the out-patients clinic or inpatient department will be
      recruited.
Study Procedures:

      On admission or during the outpatient visit:

        1. Obtaining an informed consent .

        2. Full medical history, concurrent medications, demographic data and epidemiological data
           (history of contact to a COVID-19 case, history of travel), will be obtained.

        3. A thorough physical examination will be performed.

        4. Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and
           blood oxygen saturation) will be recorded.

        5. Laboratory to perform the following tests:

      Complete blood count with differential counts, COVID -19 reverse Transcription Polymerase
      Chain Reaction (RT-PCR) test by nasopharyngeal swab.

      During admission:

      Whenever unexplained fever and or respiratory symptoms developed or whenever COVID19
      suspected to have the following to be performed:

        1. Symptom developed that necessitates to repeat oropharyngeal and nasopharyngeal swab if
           indicated will be collected

        2. Chest X-ray or CT chest will be recorded.

        3. Laboratory to perform the following tests:

      Complete blood count with differential counts,

      COVID-19 RT-PCR test by oropharyngeal and nasopharyngeal swab:

      C-reactive protein and serum ferritin level. Coagulation test; D. dimer, prothrombin time and
      INR. Routine bacteriological study, blood culture and other symptoms/signs based cultures
      will be recorded

      On discharge:

        -  Date of discharge

        -  Period of admission

        -  Period of fever

        -  A thorough physical examination will be performed

        -  Record the outcome
observational model: Case-Only
time perspective: Prospective
measure: Incidence of COVID-19 among children with cancer
time frame: 12 months
description: Measure the incidence of COVID-19 infection among children with cancer
measure: Families training
time frame: 12 months
description: Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Fatma Ebeid
role: Principal Investigator
affiliation: Excuitive Director of MARSI-CRC
last name: Fatma Ebeid
phone: +201095569596
email: dr.fatma_ebeid@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Ebeid FSE, Ragab IA, Elsherif NHK, Makkeyah S, Mostafa S, Eltonbary K, Matbouly S, Mostafa A, Goma H, Agwa SH, Hafez HM, Girgis S, El Gendy YG, El-Sayed MH. COVID-19 in Children With Cancer: A Single Low-Middle Income Center Experience. J Pediatr Hematol Oncol. 2021 Nov 1;43(8):e1077-e1081. doi: 10.1097/MPH.0000000000002025.
PMID: 33290293
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Fatma Soliman Elsayed Ebeid
investigator title: Executive Director of Faculty of Medicine Ain Shams University Research Institute - Clinical Research Center
mesh term: COVID-19
sharing ipd: No