<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/NCT04419896</url>
  </required_header>
  <id_info>
    <org_study_id>IGAP1000</org_study_id>
    <nct_id>NCT04419896</nct_id>
  </id_info>
  <brief_title>The Informed Genetics Annotated Patient Registry</brief_title>
  <acronym>iGAP</acronym>
  <official_title>The Informed Genetics Annotated Patient Registry: The iGAP Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medneon</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medneon</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>
      This prospective and retrospective registry will evaluate the clinical effectiveness of&#xD;
      Germline Genetic, Genomic, and other Biomarker testing results over time in different&#xD;
      clinical populations, in order to shape guidelines for testing, patient management, and&#xD;
      precision therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interest and knowledge about the genetics and biology of an individual's inherited risk of&#xD;
      disease and progression of disease is growing. Physicians are increasing using tests and&#xD;
      technology, including Germline Genetic, Genomic, and Biomarker Testing, to provide insight&#xD;
      into a healthy individual's risk and an affected individual's disease characteristics, in&#xD;
      order to provide individualized clinical treatments. However, many barriers to widespread and&#xD;
      appropriate Germline Genetic, Genomic, and Biomarker Testing persist due to complex&#xD;
      guidelines for use, varied quality and cost, rapid advances, and adequate understanding of&#xD;
      appropriate implementation by medical professionals. The iGAP Registry is a multi-center&#xD;
      ongoing database designed to capture information on disease risk assessment, Germline&#xD;
      Genetic, Genomic, and Biomarker Testing, and their utilization and impact on treatment&#xD;
      practices and outcomes to help determine, over time, the most effective use of testing in&#xD;
      varied patient populations and to support the increased use of precision medicine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2030</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings.</measure>
    <time_frame>10 years</time_frame>
    <description>To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. The registry will gather information on patient demographics and personal and family history, as well as test results of Germline Genetic, Genomic, and Biomarker tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing.</measure>
    <time_frame>10 years</time_frame>
    <description>To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. This registry will gather information to capture the clinical management decision making processes of the physicians, before and after receiving information from Germline Genetic, Genomic, or other Biomarker testing. Further, this registry will collect information on Patient Reported Outcomes, or patient described impacts of Germline Genetic, Genomic, or other Biomarker testing on their treatment, clinician interactions, follow-up, and mental health.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Predisposition, Genetic</condition>
  <arm_group>
    <arm_group_label>Retrospective</arm_group_label>
    <description>Inclusion criteria for Retrospective Subjects:&#xD;
Men and women 18 years or older;&#xD;
Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and&#xD;
For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective</arm_group_label>
    <description>Inclusion criteria for Prospective Subjects:&#xD;
Men and women aged 18 years or older;&#xD;
Presents consecutively to a Participating Practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a Participating Practice or is an existing patient who returns to a Participating Practice);&#xD;
Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and&#xD;
Consents to be a part of the Registry.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals 18 years or older who meet eligibility criteria, who is screened and tested for&#xD;
        or receives or has received Germline, Genomic, or other Biomarker Testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Retrospective Subjects:&#xD;
&#xD;
          -  Men and women 18 years or older;&#xD;
&#xD;
          -  Is or was a patient of a Participating Practice and was previously tested with&#xD;
             Germline, Genomic, or other Biomarker Tests; and&#xD;
&#xD;
          -  For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely&#xD;
             pathogenic (P/LP) result.&#xD;
&#xD;
        Inclusion Criteria for Prospective Subjects:&#xD;
&#xD;
          -  Men and women aged 18 years or older;&#xD;
&#xD;
          -  Presents consecutively to a Participating Practice and who has previously been&#xD;
             screened and tested (i.e., is a new patient scheduled for a visit at a Participating&#xD;
             Practice or is an existing patient who returns to a Participating Practice);&#xD;
&#xD;
          -  Receives or has received Germline, Genomic, or other Biomarker Testing, either through&#xD;
             a prior healthcare provider or a Participating Practice; and&#xD;
&#xD;
          -  Consents to be a part of the Registry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>North Valley Breast Clinic</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <zip>96001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Good Shepherd</name>
      <address>
        <city>Barrington</city>
        <state>Illinois</state>
        <zip>60010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Breast Care</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Breast Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Surgical</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Predisposition to Disease</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/NCT04419896
org study id: IGAP1000
nct id: NCT04419896
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective and retrospective registry will evaluate the clinical effectiveness of
      Germline Genetic, Genomic, and other Biomarker testing results over time in different
      clinical populations, in order to shape guidelines for testing, patient management, and
      precision therapy.
Interest and knowledge about the genetics and biology of an individual's inherited risk of
      disease and progression of disease is growing. Physicians are increasing using tests and
      technology, including Germline Genetic, Genomic, and Biomarker Testing, to provide insight
      into a healthy individual's risk and an affected individual's disease characteristics, in
      order to provide individualized clinical treatments. However, many barriers to widespread and
      appropriate Germline Genetic, Genomic, and Biomarker Testing persist due to complex
      guidelines for use, varied quality and cost, rapid advances, and adequate understanding of
      appropriate implementation by medical professionals. The iGAP Registry is a multi-center
      ongoing database designed to capture information on disease risk assessment, Germline
      Genetic, Genomic, and Biomarker Testing, and their utilization and impact on treatment
      practices and outcomes to help determine, over time, the most effective use of testing in
      varied patient populations and to support the increased use of precision medicine.
observational model: Case-Only
time perspective: Other
measure: To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings.
time frame: 10 years
description: To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. The registry will gather information on patient demographics and personal and family history, as well as test results of Germline Genetic, Genomic, and Biomarker tests.
measure: To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing.
time frame: 10 years
description: To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. This registry will gather information to capture the clinical management decision making processes of the physicians, before and after receiving information from Germline Genetic, Genomic, or other Biomarker testing. Further, this registry will collect information on Patient Reported Outcomes, or patient described impacts of Germline Genetic, Genomic, or other Biomarker testing on their treatment, clinician interactions, follow-up, and mental health.
arm group label: Retrospective
description: Inclusion criteria for Retrospective Subjects:
Men and women 18 years or older;
Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and
For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.
arm group label: Prospective
description: Inclusion criteria for Prospective Subjects:
Men and women aged 18 years or older;
Presents consecutively to a Participating Practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a Participating Practice or is an existing patient who returns to a Participating Practice);
Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and
Consents to be a part of the Registry.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Genetic Predisposition to Disease