<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/NCT02247323</url>
  </required_header>
  <id_info>
    <org_study_id>Beni-Suef 6</org_study_id>
    <nct_id>NCT02247323</nct_id>
  </id_info>
  <brief_title>Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125</brief_title>
  <acronym>CA125</acronym>
  <official_title>Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are assessing the incidence of ovarian cancer in premenopausal women who&#xD;
      were at moderate risk of malignancy with low CA125.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal&#xD;
      women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1&#xD;
      CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal&#xD;
      women due to many false positive results and reduced specificity.1 pelvic vaginal&#xD;
      ultrasonography is the most effective tool in evaluating ovarian masses due to increased&#xD;
      sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in&#xD;
      evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum&#xD;
      including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each&#xD;
      feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate&#xD;
      and more than 250 has a severe risk of malignancy needing oncologist.44/3&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of ovarian malignancy</measure>
    <time_frame>one year</time_frame>
    <description>Calculation of number of women who had ovarian cancer after an operation in moderate risk</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>premenopausal women</arm_group_label>
    <description>premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Risk of malignancy index</intervention_name>
    <description>Calculation of RMI before sugery.</description>
    <arm_group_label>premenopausal women</arm_group_label>
    <other_name>RMI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for&#xD;
        malignancy by RMI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with complex ovarian cyst&#xD;
&#xD;
          -  Abdominal pain&#xD;
&#xD;
          -  Menometrorrhagia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant weight loss&#xD;
&#xD;
          -  Cachexia&#xD;
&#xD;
          -  History of ovarian or other malignancy&#xD;
&#xD;
          -  Family history of ovarian Cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nesreen A Shehata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beni-Suef University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nesreen A Shehata, MD</last_name>
    <phone>00201227866337</phone>
    <email>nesoomar@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abdelgany M Hassan, MD</last_name>
    <phone>00201017801604</phone>
    <email>abdelgany2@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beni-Suef University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nesreen A Shehata, MD</last_name>
      <phone>00201227866337</phone>
      <email>nesoomar@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Abdelgany M Hassan, MD</last_name>
      <phone>00201017801604</phone>
    </contact_backup>
    <investigator>
      <last_name>Nesreen A Shehata, Lecturer</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abdelgany M Hassan, Lecturer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.google.com.eg/search?q=National+Institute+for+health+and+clinical+excellence.+Ovarian+cancer%3AThe+recognition+and+initial+management+of+ovarian+cancer.NICE+clinical+guideline+122.London%3ANICE%3B2011&amp;oq=National+In</url>
    <description>National Institute for health and clinical excellence. Ovarian cancer:The recognition and initial management of ovarian cancer.NICE clinical guideline 122.London:NICE;2011</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 30, 2021</last_update_submitted>
  <last_update_submitted_qc>January 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Nesreen Abdel Fattah Abdullah Shehata</investigator_full_name>
    <investigator_title>Assistant Professor of Obstetrics and Gynecology</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/NCT02247323
org study id: Beni-Suef 6
nct id: NCT02247323
lead sponsor: 
has dmc: Yes
The investigators are assessing the incidence of ovarian cancer in premenopausal women who
      were at moderate risk of malignancy with low CA125.
About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal
      women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1
      CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal
      women due to many false positive results and reduced specificity.1 pelvic vaginal
      ultrasonography is the most effective tool in evaluating ovarian masses due to increased
      sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in
      evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum
      including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each
      feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate
      and more than 250 has a severe risk of malignancy needing oncologist.44/3
observational model: Case-Only
time perspective: Retrospective
measure: Incidence of ovarian malignancy
time frame: one year
description: Calculation of number of women who had ovarian cancer after an operation in moderate risk
arm group label: premenopausal women
description: premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125.
intervention type: Other
intervention name: Risk of malignancy index
description: Calculation of RMI before sugery.
arm group label: premenopausal women
other name: RMI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 50 Years
healthy volunteers: No
last name: Nesreen A Shehata, MD
role: Principal Investigator
affiliation: Beni-Suef University
last name: Nesreen A Shehata, MD
phone: 00201227866337
email: nesoomar@yahoo.com
last name: Abdelgany M Hassan, MD
phone: 00201017801604
email: abdelgany2@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Egypt
url: http://www.google.com.eg/search?q=National+Institute+for+health+and+clinical+excellence.+Ovarian+cancer%3AThe+recognition+and+initial+management+of+ovarian+cancer.NICE+clinical+guideline+122.London%3ANICE%3B2011&oq=National+In
description: National Institute for health and clinical excellence. Ovarian cancer:The recognition and initial management of ovarian cancer.NICE clinical guideline 122.London:NICE;2011
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Nesreen Abdel Fattah Abdullah Shehata
investigator title: Assistant Professor of Obstetrics and Gynecology