<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/NCT02227654</url>
  </required_header>
  <id_info>
    <org_study_id>14-GYN-200</org_study_id>
    <nct_id>NCT02227654</nct_id>
  </id_info>
  <brief_title>Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors</brief_title>
  <official_title>Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Frederick R. Ueland, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lucille P. Markey Cancer Center at University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present investigation will prospectively evaluate whether serial transvaginal&#xD;
      ultrasonography with Morphology Index (MI) can further reduce false positive results by more&#xD;
      accurately distinguishing benign from malignant ovarian tumors. If there is no change in the&#xD;
      detection of true positive cases, the result will be an increase in the positive predictive&#xD;
      value of ovarian cancer screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To determine if a treatment algorithm using serial transvaginal ultrasound with a tumor&#xD;
      morphology index can improve the positive predictive value (PPV) of ovarian cancer screening&#xD;
      compared to a historical control from 15% to 25%.&#xD;
&#xD;
      Secondary Objective To measure the compliance for study participants enrolled on the&#xD;
      treatment algorithm using serial transvaginal ultrasound with a tumor morphology index.&#xD;
&#xD;
      Exploratory Objective To determine the effectiveness of a treatment algorithm that combines&#xD;
      serum biomarkers aloneor in combination with transvaginal ultrasound to reduce the false&#xD;
      positive rate of ovarian cancer screening in the subset of women agreeing to biomarker&#xD;
      collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2016</start_date>
  <completion_date type="Actual">September 7, 2022</completion_date>
  <primary_completion_date type="Actual">September 7, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive predictive value (PPV) of ovarian cancer screening</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Whether the treatment algorithm for patients with abnormal ultrasounds improves the positive predictive value of ultrasounds as ovarian screening tests, thus lowering the false positive rate compared to historical controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Surgical complications including type, severity, and resolution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to the treatment algorithm</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Percentage of required visits that were attended for each individual's treatment algorithm</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Ovarian Neoplasms</condition>
  <arm_group>
    <arm_group_label>Abnormal Ovarian Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abnormal Ovarian Ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Abnormal Ovarian Ultrasound</intervention_name>
    <description>Ultrasound</description>
    <arm_group_label>Abnormal Ovarian Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women must be enrolled in the University of Kentucky Ovarian Cancer Screening Program&#xD;
             Eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal&#xD;
             and have not had a prior salpingo-oophorectomy or have a family history of ovarian&#xD;
             cancer in a primary relative or have a self-history of breast cancer.&#xD;
&#xD;
          -  Patients have a documented ovarian abnormality on ultrasound&#xD;
&#xD;
          -  Patients having undergone prior hysterectomy will be eligible provided that they meet&#xD;
             the other requirements for entry into this study.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not enrolled in the University of Kentucky Ovarian Cancer Screening&#xD;
             Program .&#xD;
&#xD;
          -  Patients who cannot tolerate the vaginal ultrasound procedure.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Patients who are referred with pelvic symptoms, a known pelvic mass, or a history of&#xD;
             prior radiation, will be excluded from this investigation.&#xD;
&#xD;
          -  History of ovarian cancer.&#xD;
&#xD;
          -  Prior bilateral salpingo-oophorectomy.&#xD;
&#xD;
          -  Prisoners.&#xD;
&#xD;
          -  Women who are currently pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Because ovarian cancer is a disease of only women, men are not included in this study, but women of all races and ethnic groups are eligible for this trial.</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick R. Ueland, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Markey Cancer Center, University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Markey Cancer Center, University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Frederick R. Ueland, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ovary</keyword>
  <keyword>Cancer</keyword>
  <keyword>Morphology</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</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/NCT02227654
org study id: 14-GYN-200
nct id: NCT02227654
lead sponsor: 
collaborator: 
has dmc: Yes
The present investigation will prospectively evaluate whether serial transvaginal
      ultrasonography with Morphology Index (MI) can further reduce false positive results by more
      accurately distinguishing benign from malignant ovarian tumors. If there is no change in the
      detection of true positive cases, the result will be an increase in the positive predictive
      value of ovarian cancer screening.
Primary Objective:

      To determine if a treatment algorithm using serial transvaginal ultrasound with a tumor
      morphology index can improve the positive predictive value (PPV) of ovarian cancer screening
      compared to a historical control from 15% to 25%.

      Secondary Objective To measure the compliance for study participants enrolled on the
      treatment algorithm using serial transvaginal ultrasound with a tumor morphology index.

      Exploratory Objective To determine the effectiveness of a treatment algorithm that combines
      serum biomarkers aloneor in combination with transvaginal ultrasound to reduce the false
      positive rate of ovarian cancer screening in the subset of women agreeing to biomarker
      collection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Positive predictive value (PPV) of ovarian cancer screening
time frame: Up to 12 months
description: Whether the treatment algorithm for patients with abnormal ultrasounds improves the positive predictive value of ultrasounds as ovarian screening tests, thus lowering the false positive rate compared to historical controls.
measure: Surgical complications
time frame: Up to 12 months
description: Surgical complications including type, severity, and resolution.
measure: Compliance to the treatment algorithm
time frame: Up to 12 months
description: Percentage of required visits that were attended for each individual's treatment algorithm
arm group label: Abnormal Ovarian Ultrasound
arm group type: Experimental
description: Abnormal Ovarian Ultrasound
intervention type: Procedure
intervention name: Abnormal Ovarian Ultrasound
description: Ultrasound
arm group label: Abnormal Ovarian Ultrasound
criteria: 
gender: Female
gender based: Yes
gender description: Because ovarian cancer is a disease of only women, men are not included in this study, but women of all races and ethnic groups are eligible for this trial.
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Frederick R. Ueland, M.D.
role: Principal Investigator
affiliation: Markey Cancer Center, University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Frederick R. Ueland, M.D.
investigator title: Principal Investigator
mesh term: Ovarian Neoplasms
sharing ipd: No