<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/NCT04487405</url>
  </required_header>
  <id_info>
    <org_study_id>04-2019</org_study_id>
    <nct_id>NCT04487405</nct_id>
  </id_info>
  <brief_title>A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants</brief_title>
  <acronym>OVAnex</acronym>
  <official_title>A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aspira Women's Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aspira Women's Health</source>
  <oversight_info>
    <has_dmc>No</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>
      The objective of this project is to validate the sensitivity, specificity, positive&#xD;
      predictive value and negative predictive values of the AMRA blood test for assessing risk of&#xD;
      cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal&#xD;
      mass.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2030</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>OVAnex</measure>
    <time_frame>12 months</time_frame>
    <description>OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">4661</enrollment>
  <condition>Adnexal Mass</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Symptomatic with adnexal mass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Asymptomatic with adnexal mass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OVAnex</intervention_name>
    <description>OVAnex is a multivarite index assay assessing ovarian cancer risk</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2&#xD;
        and other germline DNA variants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in&#xD;
             follow-up due to the presence of BRCA1/2 and other germline DNA variants.&#xD;
&#xD;
          -  Patient reviewed, understood, and provided the PI with written informed consent to&#xD;
             allow blood specimen to be used for research and release of medical information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is less than 18 years of age&#xD;
&#xD;
          -  Patient is not being treated in the U.S.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Silvana Franco</last_name>
    <phone>844-277-4721</phone>
    <email>sfranco@aspirawh.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kayla Nolan</last_name>
    <phone>860-324-3180</phone>
    <email>knolan@aspirawh.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Women's Health Arizona</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Monte Swarup</last_name>
      <email>mswarup@aoafamily.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Altus Research</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>MidTown OBGYN</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Serena Tidwell</last_name>
      <email>stidwell@midtownob.com</email>
    </contact>
    <contact_backup>
      <last_name>Rebecca Watkins</last_name>
      <email>rebeccaw@midtownob.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Premier OBGYN of Minnesota</name>
      <address>
        <city>Eden Prairie</city>
        <state>Minnesota</state>
        <zip>55344</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Katie Toft</last_name>
      <email>katiet@obgynwest.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Square Care Health</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Frank Dolisi</last_name>
      <email>frank.dolisi@squarecarehealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seven Hills Clinical Research Group</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gerard Reilly, MD</last_name>
      <email>gerard.reilly@axiawh.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>May Grant OB/GYN</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Kent Meldrum</last_name>
      <email>kameldrum72@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hill Country OBGYN Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Ana Eduardo</last_name>
      <email>a.eduardo@ahcobgyn.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</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 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04487405
org study id: 04-2019
nct id: NCT04487405
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this project is to validate the sensitivity, specificity, positive
      predictive value and negative predictive values of the AMRA blood test for assessing risk of
      cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal
      mass.
observational model: Case-Control
time perspective: Other
measure: OVAnex
time frame: 12 months
description: OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.
arm group label: Group A
description: Symptomatic with adnexal mass
arm group label: Group B
description: Asymptomatic with adnexal mass
arm group label: Group C
description: Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant
intervention type: Device
intervention name: OVAnex
description: OVAnex is a multivarite index assay assessing ovarian cancer risk
arm group label: Group A
arm group label: Group B
arm group label: Group C
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Silvana Franco
phone: 844-277-4721
email: sfranco@aspirawh.com
last name: Kayla Nolan
phone: 860-324-3180
email: knolan@aspirawh.com
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No