<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/NCT02209389</url>
  </required_header>
  <id_info>
    <org_study_id>OctavaPink for Dense Breast</org_study_id>
    <nct_id>NCT02209389</nct_id>
  </id_info>
  <brief_title>OctavaPink for Women With Dense Breast After Negative Mammography</brief_title>
  <official_title>OctavaPink® For Dense Breast After Negative Mammography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eventus Diagnostics Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eventus Diagnostics Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in&#xD;
      asymptomatic women for whom screening or diagnostic mammography findings are normal or benign&#xD;
      (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3&#xD;
      or 4). The device is intended to increase breast cancer detection in the described patient&#xD;
      population. Based upon the result of OctavaPink, the patient will be further evaluated by&#xD;
      their physician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, prospective study containing 3 parts:&#xD;
&#xD;
      Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as&#xD;
      follows:&#xD;
&#xD;
      Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not&#xD;
      affect the treatment of the participants. Part 1A is an internal part done by EventusDx and&#xD;
      no statistical evaluation is needed.&#xD;
&#xD;
      Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70%&#xD;
      sensitivity.&#xD;
&#xD;
      Part 1B will assess the properties of the OctavaPink test using cases and controls obtained&#xD;
      via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test&#xD;
      must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control&#xD;
      status before using the test to affect clinical management of patients.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      (i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of&#xD;
      cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same&#xD;
      properties in the subset of cases with invasive cancer (IDC and ILC).&#xD;
&#xD;
      (ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.&#xD;
&#xD;
      Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a&#xD;
      positive OctavaPink test result in the dense breast negative mammography population.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      (i) To compare the yield of cancer detection via MRI/biopsy among women with a positive&#xD;
      OctavaPink test versus a negative OctavaPink test result.&#xD;
&#xD;
      (ii) To estimate the proportion of patients who are positive for the test in the target&#xD;
      population&#xD;
&#xD;
      Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with&#xD;
      dense breasts and negative mammography.&#xD;
&#xD;
      Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and&#xD;
      negative mammography that is broadly consistent with that found in the dense breast&#xD;
      population (but not necessarily negative mammogram) in Parts 1A and 1B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Positive MRI as an approval for a positive OctavaPink test</measure>
    <time_frame>Approximately two month following a positive Octava test</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1750</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Positive OctavaPink</arm_group_label>
    <description>Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative OctavaPink - control</arm_group_label>
    <description>For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and recalled for an MRI and any additional testing (required by the MRI).&#xD;
MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).</description>
    <arm_group_label>Negative OctavaPink - control</arm_group_label>
    <arm_group_label>Positive OctavaPink</arm_group_label>
    <other_name>Magnetic Resonance Imaging</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population for all parts of the protocol includes women above 30, who have had a&#xD;
        mammography in the past 5-18 months, for which the result was negative (BIRADS assessment&#xD;
        category 1 or 2), and on which they were defined as having dense breast tissue (BIRADS&#xD;
        composition/density 3 or 4).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with dense breast tissue according to ACR criteria, (BIRADS&#xD;
             composition/density 3 or 4), or with specific area of high density behind the nipple.&#xD;
&#xD;
          -  Subject with current mammography BIRADS assessment category other than 3.&#xD;
&#xD;
          -  Signed inform consent form.&#xD;
&#xD;
        Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases&#xD;
&#xD;
        • Subjects with current biopsy/surgery proven breast cancer.&#xD;
&#xD;
        Additional inclusion criteria for Part 1A controls, Part 1B controls • Subjects with&#xD;
        current negative mammography (BIRADS assessment category 1 or 2).&#xD;
&#xD;
        Additional inclusion criteria for Part 2&#xD;
&#xD;
        • Subjects with current negative mammography (BIRADS assessment category 1 or 2). All will&#xD;
        perform an additional 1 year (12-18 months) up mammography to verify negative results.&#xD;
&#xD;
        Additional inclusion criteria for Part 3 • Enriched patient population - Subjects with&#xD;
        current/recent (less than 12 months) negative mammography (BIRADS assessment category 1 or&#xD;
        2). Mammography evaluation can be performed after recruiting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or concurrent malignancies of any type except for basal cell carcinoma of the&#xD;
             skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.&#xD;
&#xD;
          -  Previous or current ADH, ALH, LCIS.&#xD;
&#xD;
          -  Autoimmune disorders diagnosed subjects.&#xD;
&#xD;
          -  Hematological malignancies.&#xD;
&#xD;
          -  Subjects under active chemotherapy treatment or chemotherapy in the past 6 months.&#xD;
&#xD;
          -  Steroid treatment in the past 3 months.&#xD;
&#xD;
          -  Subject undergoing immunosuppressive treatments.&#xD;
&#xD;
          -  Subject with current mammography BIRADS assessment category of 3.&#xD;
&#xD;
          -  Pregnancy at time of recruitment.&#xD;
&#xD;
          -  Doctor medical judgment that prohibits participation in the study.&#xD;
&#xD;
          -  Participating in a parallel clinical study that involves drug treatment, or may&#xD;
             influence the course of this clinical trial.&#xD;
&#xD;
        Additional exclusion criteria for Part 3&#xD;
&#xD;
        • Subjects with current mammography BIRADS assessment other than 1 or 2.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edith Perez, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic, Jacksonville Florida USA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Galit Yahalom, PhD.</last_name>
    <phone>+97226738854</phone>
    <email>galit@eventusdx.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Cohen, CRA</last_name>
    <phone>+97226738854</phone>
    <email>sarah@eventusdx.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Detroit Clinical Research Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Benjamin Taggart, B.S.</last_name>
      <phone>248-716-7009</phone>
      <email>benjamin.taggart@dcrc.us</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson cancer center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <investigator>
      <last_name>Bevers, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shaarey Tzedek</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Strano, Prof.</last_name>
      <email>strano@szmc.org.il</email>
    </contact>
    <investigator>
      <last_name>Strano, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shiba</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Sklair, Dr.</last_name>
      <email>Miri.SklairLevy@sheba.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Sklair, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaplan medical center</name>
      <address>
        <city>Rehovot</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Tanir Allweis, Dr.</last_name>
      <email>tanirallweis@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Tanir Allweis, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sourasky medical center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Orit Golan, Dr.</last_name>
      <email>oritgolan@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Orit Golan, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione Carlo ferri</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Iacobelli, Dr.</last_name>
      <email>daniela.iacobelli@alice.it</email>
    </contact>
    <investigator>
      <last_name>Iacobelli, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <reference>
    <citation>Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013.</citation>
    <PMID>24324350</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>cancer associated auto antibodies</keyword>
  <keyword>breast cancer blood test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT02209389
org study id: OctavaPink for Dense Breast
nct id: NCT02209389
lead sponsor: 
has dmc: No
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in
      asymptomatic women for whom screening or diagnostic mammography findings are normal or benign
      (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3
      or 4). The device is intended to increase breast cancer detection in the described patient
      population. Based upon the result of OctavaPink, the patient will be further evaluated by
      their physician.
This is a multicenter, prospective study containing 3 parts:

      Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as
      follows:

      Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not
      affect the treatment of the participants. Part 1A is an internal part done by EventusDx and
      no statistical evaluation is needed.

      Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70%
      sensitivity.

      Part 1B will assess the properties of the OctavaPink test using cases and controls obtained
      via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test
      must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control
      status before using the test to affect clinical management of patients.

      Objectives:

      (i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of
      cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same
      properties in the subset of cases with invasive cancer (IDC and ILC).

      (ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.

      Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a
      positive OctavaPink test result in the dense breast negative mammography population.

      Objectives:

      (i) To compare the yield of cancer detection via MRI/biopsy among women with a positive
      OctavaPink test versus a negative OctavaPink test result.

      (ii) To estimate the proportion of patients who are positive for the test in the target
      population

      Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with
      dense breasts and negative mammography.

      Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and
      negative mammography that is broadly consistent with that found in the dense breast
      population (but not necessarily negative mammogram) in Parts 1A and 1B.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Positive MRI as an approval for a positive OctavaPink test
time frame: Approximately two month following a positive Octava test
arm group label: Positive OctavaPink
description: Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).
arm group label: Negative OctavaPink - control
description: For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and recalled for an MRI and any additional testing (required by the MRI).
MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result.
intervention type: Device
intervention name: MRI
description: For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).
arm group label: Negative OctavaPink - control
arm group label: Positive OctavaPink
other name: Magnetic Resonance Imaging
Human plasma samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edith Perez, Prof.
role: Principal Investigator
affiliation: Mayo Clinic, Jacksonville Florida USA
last name: Galit Yahalom, PhD.
phone: +97226738854
email: galit@eventusdx.com
last name: Sarah Cohen, CRA
phone: +97226738854
email: sarah@eventusdx.com
facility: 
contact: 
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investigator: 
facility: 
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country: Israel
country: Italy
country: United States
country: Canada
citation: Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013.
PMID: 24324350
responsible party type: Sponsor
mesh term: Breast Neoplasms