<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/NCT01683305</url>
  </required_header>
  <id_info>
    <org_study_id>Silbiotech:2012-01</org_study_id>
    <nct_id>NCT01683305</nct_id>
  </id_info>
  <brief_title>Biomarker Breast Pap Test</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silbiotech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Silbiotech</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of&#xD;
      cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically&#xD;
      detectable tumors, and those who have detectable tumors, 2) identify all the detectable&#xD;
      markers and 3) establish that biomarkers detected in NAF could also be detected in the&#xD;
      biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Tumors</condition>
  <arm_group>
    <arm_group_label>Subjects who have no mammographically detectable tumors</arm_group_label>
    <description>This group will be evaluated for marker presence in NAF. no drugs administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects who have non-cancerous growths</arm_group_label>
    <description>This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>subjects who have cancerous growths</arm_group_label>
    <description>In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any woman age 18 or older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any female subject aged 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Silbiotech</investigator_affiliation>
    <investigator_full_name>Indira Poola, Ph.D</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>biomarker,</keyword>
  <keyword>NAF</keyword>
  <keyword>Subjects</keyword>
  <!-- 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/NCT01683305
org study id: Silbiotech:2012-01
nct id: NCT01683305
lead sponsor: 
has dmc: No
This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of
      cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically
      detectable tumors, and those who have detectable tumors, 2) identify all the detectable
      markers and 3) establish that biomarkers detected in NAF could also be detected in the
      biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable
      tumors.
observational model: Cohort
arm group label: Subjects who have no mammographically detectable tumors
description: This group will be evaluated for marker presence in NAF. no drugs administered
arm group label: Subjects who have non-cancerous growths
description: This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered
arm group label: subjects who have cancerous growths
description: In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Silbiotech
investigator full name: Indira Poola, Ph.D
investigator title: Principal Investigator