<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/NCT03837327</url>
  </required_header>
  <id_info>
    <org_study_id>OVACA-001</org_study_id>
    <nct_id>NCT03837327</nct_id>
  </id_info>
  <brief_title>Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy</brief_title>
  <acronym>VOCAL</acronym>
  <official_title>Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy (VOCAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venn Biosciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venn Biosciences Corporation</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>
      Venn Biosciences Corporation (&quot;InterVenn&quot;) has developed a liquid biopsy that is capable of&#xD;
      distinguishing benign from malignant masses in women presenting with adnexal (pelvic) masses,&#xD;
      through a simple blood test. The underlying technology combines mass spectrometry and&#xD;
      artificial intelligence/machine learning to analyze tumor-associated changes in circulating&#xD;
      glycoproteins.&#xD;
&#xD;
      The purpose of this study is to prospectively collect de-identified biological samples and&#xD;
      data from women with a known pelvic mass, in order to validate ovarian cancer specific&#xD;
      glycoproteomic signatures in the blood based on histologically confirmed malignancy status of&#xD;
      the mass.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, international, multi-center, observational study with a goal of&#xD;
      collecting de-identified samples and data from 1,200 women with a known pelvic mass.&#xD;
      Participants will consent to baseline and follow-up data and biospecimen collections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test</measure>
    <time_frame>24-48 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the association of protein and glycoprotein (GP) biomarkers with histological subtypes, stage, treatments and disease free survival (DFS) among woman with ovarian cancer</measure>
    <time_frame>24-48 Months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Adnexal Mass</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Pelvic Mass</condition>
  <arm_group>
    <arm_group_label>Adnexal Mass</arm_group_label>
    <description>Women with an adnexal mass (pelvic mass) as confirmed by imaging</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult women who present with a known adnexal mass as described in the study inclusion and&#xD;
        exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women age 18 years or older&#xD;
&#xD;
          -  Able to provide a written informed consent and who understand and agree to all study&#xD;
             procedures required&#xD;
&#xD;
          -  A newly diagnosed adnexal mass as confirmed by imaging (computed tomography,&#xD;
             ultrasonography, or magnetic resonance imaging) prior to enrollment&#xD;
&#xD;
          -  Planned diagnostic procedure or surgery by the subject's physician to remove adnexal&#xD;
             masses within 90 days of imaging. (Note that diagnostic procedure typically includes&#xD;
             biopsy (needle core or laparoscopic-directed), ascites cytology, pleural effusion&#xD;
             cytology or FNA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had/Has a diagnosis of invasive malignancy (exception: non-melanoma skin cancers) in&#xD;
             the previous 5 years.&#xD;
&#xD;
          -  Currently receiving or ever received any of the following prior cancer therapies in&#xD;
             the previous 5 years. This includes curative surgical resection, local or systemic&#xD;
             chemotherapy, targeted therapy, immunotherapy including cancer vaccines, hormone&#xD;
             therapy, and/or radiation therapy.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current febrile illness&#xD;
&#xD;
          -  Acute exacerbation or flare of an inflammatory condition requiring escalation in&#xD;
             therapy&#xD;
&#xD;
          -  Recipient of organ transplant&#xD;
&#xD;
          -  Poor health status or unfit to tolerate blood draw&#xD;
&#xD;
        In addition, this study will include a small subgroup of women with a newly diagnosed&#xD;
        clinically benign adnexal mass(es) for whom surgery is not planned as determined by the&#xD;
        treating physician. This subgroup will follow the same exclusion criteria as listed above.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Per eligibility, individuals must have a known adnexal mass (pelvic mass).</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Hommes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>InterVenn Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Gynecology Oncology</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Medical Foundation</name>
      <address>
        <city>Sunnyvale</city>
        <state>California</state>
        <zip>94086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida USF Health, OB/Gyn</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Sudarshan K. Sharma, Ltd. - Gynecologic Oncology</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimum Clinical Research Group - Southwest Women's Oncology &amp; Health</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Women's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sultan Ismail</name>
      <address>
        <city>Johor Bahru</city>
        <state>Johor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Raja Perempuan Zainab II</name>
      <address>
        <city>Kota Bharu</city>
        <state>Kelantan</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ampang</name>
      <address>
        <city>Ampang</city>
        <state>Kuala Lumpur</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Tengku Ampuan Afzan</name>
      <address>
        <city>Kuantan</city>
        <state>Pahang</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Seberang Jaya</name>
      <address>
        <city>Seberang Jaya</city>
        <state>Penang</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Raja Permaisuri Bainun</name>
      <address>
        <city>Ipoh</city>
        <state>Perak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Taiping</name>
      <address>
        <city>Taiping</city>
        <state>Perak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Wanita Dan Kanak-kanak Sabah</name>
      <address>
        <city>Kota Kinabalu</city>
        <state>Sabah</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Umum Sarawak</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miri</name>
      <address>
        <city>Miri</city>
        <state>Sarawak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sibu</name>
      <address>
        <city>Sibu</city>
        <state>Sarawak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Selayang</name>
      <address>
        <city>Batu Caves</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical City</name>
      <address>
        <city>Pasig City</city>
        <state>Metro Manila</state>
        <zip>1605</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Kidney and Transplant Institute</name>
      <address>
        <city>Quezon City</city>
        <state>National Capital Region</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Philippine General Hospital</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>InterVenn</keyword>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Liquid Biopsy</keyword>
  <keyword>Mass Spectrometry</keyword>
  <keyword>Adnexal Mass/ Pelvic Mass</keyword>
  <keyword>Venn Biosciences</keyword>
  <keyword>VOCAL Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <!-- 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/NCT03837327
org study id: OVACA-001
nct id: NCT03837327
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Venn Biosciences Corporation ("InterVenn") has developed a liquid biopsy that is capable of
      distinguishing benign from malignant masses in women presenting with adnexal (pelvic) masses,
      through a simple blood test. The underlying technology combines mass spectrometry and
      artificial intelligence/machine learning to analyze tumor-associated changes in circulating
      glycoproteins.

      The purpose of this study is to prospectively collect de-identified biological samples and
      data from women with a known pelvic mass, in order to validate ovarian cancer specific
      glycoproteomic signatures in the blood based on histologically confirmed malignancy status of
      the mass.
This is a prospective, international, multi-center, observational study with a goal of
      collecting de-identified samples and data from 1,200 women with a known pelvic mass.
      Participants will consent to baseline and follow-up data and biospecimen collections.
observational model: Cohort
time perspective: Prospective
measure: To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the VOCAL test
time frame: 24-48 Months
measure: To evaluate the association of protein and glycoprotein (GP) biomarkers with histological subtypes, stage, treatments and disease free survival (DFS) among woman with ovarian cancer
time frame: 24-48 Months
arm group label: Adnexal Mass
description: Women with an adnexal mass (pelvic mass) as confirmed by imaging
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Per eligibility, individuals must have a known adnexal mass (pelvic mass).
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Hommes, MD
role: Study Chair
affiliation: InterVenn Biosciences
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country: Australia
country: Malaysia
country: Philippines
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial