<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/NCT03243877</url>
  </required_header>
  <id_info>
    <org_study_id>POC-BC-0217</org_study_id>
    <nct_id>NCT03243877</nct_id>
  </id_info>
  <brief_title>Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older</brief_title>
  <official_title>Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity &amp; Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>POC Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>POC Medical Systems, Inc.</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>
      POC Medical Systems has developed a Point of Care system for the screening of breast cancer&#xD;
      in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to&#xD;
      determine breast cancer's risk level for a subject by identifying the presence in plasma of&#xD;
      known biomarkers. The present study aims to determine the Sensitivity and Specificity of the&#xD;
      test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2400 subjects will be screened for breast cancer in seven enrolling sites across the country&#xD;
      to ensure diverse ethnicity.&#xD;
&#xD;
      &quot;Positive&quot; subjects should be confirmed breast cancer positive by Mammography and/or biopsy.&#xD;
      Breast cancer positive samples will be compared to the control group of samples obtained from&#xD;
      women attending clinics for non-cancerous related pathology.&#xD;
&#xD;
      Both Positive and Negative Predictive Values will be evaluated to determine accuracy and&#xD;
      sensitivity of the screening test.&#xD;
&#xD;
      Subjects whose known cancer positive or negative status do not match the test report will be&#xD;
      followed up as appropriate, on case by case basis to identify false positive and false&#xD;
      negative results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 17, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 26, 2017</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>Screening performance (i.e., sensitivity and specificity)</measure>
    <time_frame>Screening performance will be calculated at 4-months</time_frame>
    <description>Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive values &amp; likelihood ratios</measure>
    <time_frame>Predictive values &amp; likelihood ratios will be calculated at 4-months</time_frame>
    <description>Positive predictive value: the probability that a subject has the disease given that the test result is positive will be estimated by: TP/(TP+FP).&#xD;
Negative predictive value: the probability that a subject does not have the disease given that the result of the test is negative will be estimated by TN/(TN+FN).&#xD;
Likelihood ratio (LR): the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that that same result would be expected in a patient without the target disorder.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Accuracy of test</measure>
    <time_frame>Accuracy of test will be calculated at 4-months</time_frame>
    <description>The probability that the test result reflects the true disease state will be estimated as the proportion of cases for which the test result is correct: (TP+TN)/(TP+FP+TN+FN).</description>
  </other_outcome>
  <other_outcome>
    <measure>Reproducibility</measure>
    <time_frame>Reproducibility will be calculated at 4-months</time_frame>
    <description>The ability of MammoAlert™ to reveal the same result when repeatedly performed on the same sample, assessed repeatedly by the same reader</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2458</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Breast Cancer Positive</arm_group_label>
    <description>A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive.&#xD;
MammoAlert Screening Test will be performed on plasma obtained from the blood sample.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast Cancer Negative</arm_group_label>
    <description>A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative.&#xD;
MammoAlert Screening Test will be performed on plasma obtained from the blood sample.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MammoAlert Screening Test</intervention_name>
    <description>Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.</description>
    <arm_group_label>Breast Cancer Negative</arm_group_label>
    <arm_group_label>Breast Cancer Positive</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The present study targets women of at least 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to give informed consent. Written informed consent by the patient/patient's&#xD;
             legally acceptable representative (LAR) for donating blood sample&#xD;
&#xD;
          2. Documented absence of cancer (other than Breast Cancer)&#xD;
&#xD;
          3. Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any&#xD;
             stage&#xD;
&#xD;
          4. Blood sample taken before any treatment for Breast Cancer was administered to the&#xD;
             subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.&#xD;
&#xD;
          2. Therapies for breast cancer that have been administered within 1 year of obtaining the&#xD;
             sample&#xD;
&#xD;
          3. Any condition (including psychiatric), which in the Investigator's opinion, places the&#xD;
             patient at undue risk by participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Raghu Ram Pillarisetti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indo American Cancer Hospital and Research Institute</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCG MULTI Specialty Hospital HCG Cancer Center</name>
      <address>
        <city>Ahmadabad</city>
        <state>Gujarat</state>
        <zip>380006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manipal Hospital</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amrita Institute of Medical Sciences and Research Centre</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tata Medical Center</name>
      <address>
        <city>Kolkata</city>
        <state>WEST Bengal</state>
        <zip>700160</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maulana Azad Medical College University of Delhi &amp; Associated Lok Nayak Hospital</name>
      <address>
        <city>New Delhi</city>
        <zip>110002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Screening</keyword>
  <keyword>Mammography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT03243877
org study id: POC-BC-0217
nct id: NCT03243877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
POC Medical Systems has developed a Point of Care system for the screening of breast cancer
      in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to
      determine breast cancer's risk level for a subject by identifying the presence in plasma of
      known biomarkers. The present study aims to determine the Sensitivity and Specificity of the
      test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
2400 subjects will be screened for breast cancer in seven enrolling sites across the country
      to ensure diverse ethnicity.

      "Positive" subjects should be confirmed breast cancer positive by Mammography and/or biopsy.
      Breast cancer positive samples will be compared to the control group of samples obtained from
      women attending clinics for non-cancerous related pathology.

      Both Positive and Negative Predictive Values will be evaluated to determine accuracy and
      sensitivity of the screening test.

      Subjects whose known cancer positive or negative status do not match the test report will be
      followed up as appropriate, on case by case basis to identify false positive and false
      negative results.
observational model: Cohort
time perspective: Prospective
measure: Screening performance (i.e., sensitivity and specificity)
time frame: Screening performance will be calculated at 4-months
description: Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients.
measure: Predictive values & likelihood ratios
time frame: Predictive values & likelihood ratios will be calculated at 4-months
description: Positive predictive value: the probability that a subject has the disease given that the test result is positive will be estimated by: TP/(TP+FP).
Negative predictive value: the probability that a subject does not have the disease given that the result of the test is negative will be estimated by TN/(TN+FN).
Likelihood ratio (LR): the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that that same result would be expected in a patient without the target disorder.
measure: Accuracy of test
time frame: Accuracy of test will be calculated at 4-months
description: The probability that the test result reflects the true disease state will be estimated as the proportion of cases for which the test result is correct: (TP+TN)/(TP+FP+TN+FN).
measure: Reproducibility
time frame: Reproducibility will be calculated at 4-months
description: The ability of MammoAlert™ to reveal the same result when repeatedly performed on the same sample, assessed repeatedly by the same reader
arm group label: Breast Cancer Positive
description: A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive.
MammoAlert Screening Test will be performed on plasma obtained from the blood sample.
arm group label: Breast Cancer Negative
description: A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative.
MammoAlert Screening Test will be performed on plasma obtained from the blood sample.
intervention type: Other
intervention name: MammoAlert Screening Test
description: Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.
arm group label: Breast Cancer Negative
arm group label: Breast Cancer Positive
Plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women only
minimum age: 18 Years
maximum age: N/A
last name: Raghu Ram Pillarisetti, MD
role: Principal Investigator
affiliation: KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No