<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/NCT03298100</url>
  </required_header>
  <id_info>
    <org_study_id>3176af</org_study_id>
    <nct_id>NCT03298100</nct_id>
  </id_info>
  <brief_title>Risk Scoring Model for Endometrial Cancer</brief_title>
  <acronym>Cohort</acronym>
  <official_title>Assessment of Risk Scoring Model for Prediction of Endometrial Cancer Among Symptomatic Postmenopausal Women(a Prospective Cohort Study).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension,&#xD;
      endometrial thickness and age) scoring model for prediction of endometrial carcinoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Anticipated">March 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Specificity and sensitivity of RHEA scoring mdel</measure>
    <time_frame>One year</time_frame>
    <description>Positive and negative productive values, specificity and sensitivity of RHEA scoring model</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variables to increase specificity and sensitivity of the score model</measure>
    <time_frame>One year</time_frame>
    <description>Obesity, diabetes mellitus and family history</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Oncology</condition>
  <arm_group>
    <arm_group_label>Postmenopausal women</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scoring model</intervention_name>
    <description>Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each</description>
    <arm_group_label>Postmenopausal women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All postmenopausal women (who had their menses stopped for at least one year above age of&#xD;
        40) with vaginal bleeding.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All postmenopausalwomen with vaginal bleeding and endometrial thickness more than 4 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  all patients with vaginal bleeding arising from cervical or vaginal or vulval disease&#xD;
             or due to hormonal replacement therapy (scheduled bleeding).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asmaa F Kasem</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>54678</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Asmaa Fahmy Kasem</investigator_full_name>
    <investigator_title>Assistant lecturer of obestetric and gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial 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>


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/NCT03298100
org study id: 3176af
nct id: NCT03298100
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective cohort study to assess RHEA ( recurrent vaginal bleeding, hypertension,
      endometrial thickness and age) scoring model for prediction of endometrial carcinoma
observational model: Cohort
time perspective: Prospective
measure: Specificity and sensitivity of RHEA scoring mdel
time frame: One year
description: Positive and negative productive values, specificity and sensitivity of RHEA scoring model
measure: Variables to increase specificity and sensitivity of the score model
time frame: One year
description: Obesity, diabetes mellitus and family history
arm group label: Postmenopausal women
intervention type: Other
intervention name: Scoring model
description: Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each
arm group label: Postmenopausal women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Asmaa F Kasem
role: Principal Investigator
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Asmaa Fahmy Kasem
investigator title: Assistant lecturer of obestetric and gynecology
mesh term: Endometrial Neoplasms
sharing ipd: Undecided