<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/NCT03240172</url>
  </required_header>
  <id_info>
    <org_study_id>17200101</org_study_id>
    <nct_id>NCT03240172</nct_id>
  </id_info>
  <brief_title>Assessment of DNA Damage Due to Ionizing Radiation</brief_title>
  <official_title>Assessment of DNA Damage and Capacity of DNA Repair System Among Nuclear Medicine and Clinical Oncology Workers Exposing to Ionizing Radiation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <brief_summary>
    <textblock>
      detection of DNA damage due to occupational exposure to low dose ionizing radiation using&#xD;
      comet assay technique and genotyping of certain DNA repair genes to detect inherited&#xD;
      polymorphism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>detection of DNA damage due to occupational exposure to ionizing radiation</measure>
    <time_frame>6 month</time_frame>
    <description>comet assay technique will be used</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Occupational Exposure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Case control study that will include 100 participants (50 radiation exposed workers will be&#xD;
        compared with 50 healthy age and sex-matched control group not exposed to radiation.&#xD;
&#xD;
        G power program was used to calculate the sample size for two independent groups. power&#xD;
        calculation estimated to detect an effect size of 0.88 of difference between means of two&#xD;
        independent groups, with a p value &lt; 0.05 and 80% power,.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • The radiation exposed workers will include nurses, technicians and physicians.&#xD;
&#xD;
        These persons will be occupationally exposed to different radiation sources.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of diagnostic X-rays, radiotherapy and/or chemotherapy 12 months prior to&#xD;
             sampling.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>asmaa HA mohamed, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>asmaa HA mohamed, PHD</last_name>
    <phone>01027029243</phone>
    <email>asmaahasan@aun.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>amal RA ibrahim, lecturer</last_name>
    <phone>010022454482</phone>
    <email>amal3774rayan@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71511</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>amal RA Ibrahim, lecturer</last_name>
      <phone>002010022454482</phone>
      <email>amal3774rayan@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>aml AL mohamed, lecturer</last_name>
      <phone>002010016353580</phone>
      <email>aml_aly@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>asmaa mohamed</investigator_full_name>
    <investigator_title>Director, clinical research</investigator_title>
  </responsible_party>
  <!-- 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/NCT03240172
org study id: 17200101
nct id: NCT03240172
lead sponsor: 
detection of DNA damage due to occupational exposure to low dose ionizing radiation using
      comet assay technique and genotyping of certain DNA repair genes to detect inherited
      polymorphism.
observational model: Case-Control
time perspective: Retrospective
measure: detection of DNA damage due to occupational exposure to ionizing radiation
time frame: 6 month
description: comet assay technique will be used
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: asmaa HA mohamed, PHD
role: Principal Investigator
affiliation: Assiut University
last name: asmaa HA mohamed, PHD
phone: 01027029243
email: asmaahasan@aun.edu.eg
last name: amal RA ibrahim, lecturer
phone: 010022454482
email: amal3774rayan@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: asmaa mohamed
investigator title: Director, clinical research