<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/NCT04494945</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00020629</org_study_id>
    <secondary_id>NCI-2020-04627</secondary_id>
    <secondary_id>STUDY00020629</secondary_id>
    <secondary_id>U01CA232819</secondary_id>
    <nct_id>NCT04494945</nct_id>
  </id_info>
  <brief_title>Identifying and Caring for Individuals With Inherited Cancer Syndrome</brief_title>
  <official_title>Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</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 trial examines approaches to identify and care for individuals with inherited cancer&#xD;
      syndrome. The purpose of this study is to offer no cost genetic testing to the general&#xD;
      public. Researchers hope to learn the value of providing broad, public-wide testing for high&#xD;
      risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of&#xD;
      only testing people whose families are known to be high risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two&#xD;
      proposed screening populations compared to current guidelines.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Measure adherence to current guidelines for screening and prophylactic intervention of&#xD;
      Cohorts B and C compared to Cohort A to show non-inferiority.&#xD;
&#xD;
      II. Measure the efficiency of cascade testing (defined as the ratio of family members&#xD;
      screened over total possible) for Cohorts B and C compared to Cohort A to show&#xD;
      non-inferiority.&#xD;
&#xD;
      III. Determine the costs and effectiveness, specifically quality adjusted life years (QALYs)&#xD;
      associated with genetic screening models based on Cohorts B and C to estimate incremental&#xD;
      cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable&#xD;
      cost effectiveness threshold.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo collection of saliva samples for genetic testing. If genetic test is&#xD;
      positive, patients receive genetic counseling. Patients also complete a survey about cancer&#xD;
      prevention, screening, and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 9, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2030</completion_date>
  <primary_completion_date type="Anticipated">June 10, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Determine the costs and effectiveness, specifically Quality Adjusted Life Years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>For Lynch syndrome we identify compliance as colonoscopy in past two years and bilateral salpingo-oophorectomy (BSO ) after child-bearing age. For HBOC, compliance is defined as breast imaging in past year or risk reducing surgery at any point in women.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cascade screening rate among Lynch or HBOC positive carriers</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">27500</enrollment>
  <condition>BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome</condition>
  <condition>Breast Ductal Carcinoma In Situ</condition>
  <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
  <condition>Hereditary Neoplastic Syndrome</condition>
  <condition>Lynch Syndrome</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of saliva sample</description>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Counseling</intervention_name>
    <description>Receive genetic counseling if testing results are positive</description>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Testing</intervention_name>
    <description>Undergo genetic testing</description>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
    <other_name>genetic analysis</other_name>
    <other_name>Genetic Examination</other_name>
    <other_name>Genetic Test</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Complete a survey</description>
    <arm_group_label>Screening (genetic testing)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ALL COHORTS: 18 years of age or older&#xD;
&#xD;
          -  Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively&#xD;
             consent&#xD;
&#xD;
          -  Retrospective COHORT A: Patients may or may not be diagnosed with cancer&#xD;
&#xD;
          -  Retrospective COHORT A: Patients have received genetic counseling in the past 5 years&#xD;
&#xD;
          -  Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2&#xD;
             and/or Lynch syndrome&#xD;
&#xD;
          -  COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver,&#xD;
             Cohort A returns survey as consent&#xD;
&#xD;
          -  COHORT A: Patients may or may not be diagnosed with cancer&#xD;
&#xD;
          -  COHORT A: Patients have received genetic counseling in the past 1 - 2 years&#xD;
&#xD;
          -  COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch&#xD;
             syndrome&#xD;
&#xD;
          -  COHORT A: INCLUSIVE of no contact list to exclude from Cohort B&#xD;
&#xD;
          -  COHORT B: Creation of secure Medable account&#xD;
&#xD;
          -  COHORT B: Consent to this project, either hard or electronic signature&#xD;
&#xD;
          -  COHORT B: Consent to the Healthy Oregon Project (HOP) repository, either hard or&#xD;
             electronic signature&#xD;
&#xD;
          -  COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample&#xD;
&#xD;
          -  COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable&#xD;
             cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer&#xD;
&#xD;
          -  COHORT B: Must have had an encounter within past twelve months&#xD;
&#xD;
          -  COHORT B: Exclude Cohort A&#xD;
&#xD;
          -  COHORT C: Creation of secure Medable account&#xD;
&#xD;
          -  COHORT C: Consent to this project, either hard or electronic signature&#xD;
&#xD;
          -  COHORT C: Consent to the HOP repository, either hard or electronic signature&#xD;
&#xD;
          -  COHORT C: Choosing to submit a DNA sample&#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>
  <overall_official>
    <last_name>Jackilen Shannon, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bill J. Wright, Ph.D.</last_name>
      <email>Bill.Wright@providence.org</email>
    </contact>
    <investigator>
      <last_name>Bill J. Wright, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jackilen Shannon, Ph.D.</last_name>
      <phone>503-494-4993</phone>
      <email>shannoja@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Jackilen Shannon, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Jackie Shannon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Ductal</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Hereditary Breast and Ovarian Cancer Syndrome</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
    <mesh_term>Neoplastic Syndromes, Hereditary</mesh_term>
    <mesh_term>Syndrome</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/NCT04494945
org study id: STUDY00020629
secondary id: NCI-2020-04627
secondary id: STUDY00020629
secondary id: U01CA232819
nct id: NCT04494945
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This trial examines approaches to identify and care for individuals with inherited cancer
      syndrome. The purpose of this study is to offer no cost genetic testing to the general
      public. Researchers hope to learn the value of providing broad, public-wide testing for high
      risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of
      only testing people whose families are known to be high risk.
PRIMARY OBJECTIVE:

      I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two
      proposed screening populations compared to current guidelines.

      SECONDARY OBJECTIVES:

      I. Measure adherence to current guidelines for screening and prophylactic intervention of
      Cohorts B and C compared to Cohort A to show non-inferiority.

      II. Measure the efficiency of cascade testing (defined as the ratio of family members
      screened over total possible) for Cohorts B and C compared to Cohort A to show
      non-inferiority.

      III. Determine the costs and effectiveness, specifically quality adjusted life years (QALYs)
      associated with genetic screening models based on Cohorts B and C to estimate incremental
      cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable
      cost effectiveness threshold.

      OUTLINE:

      Patients undergo collection of saliva samples for genetic testing. If genetic test is
      positive, patients receive genetic counseling. Patients also complete a survey about cancer
      prevention, screening, and treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
time frame: Up to 5 years
description: Determine the costs and effectiveness, specifically Quality Adjusted Life Years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold.
measure: Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
time frame: Up to 5 years
description: For Lynch syndrome we identify compliance as colonoscopy in past two years and bilateral salpingo-oophorectomy (BSO ) after child-bearing age. For HBOC, compliance is defined as breast imaging in past year or risk reducing surgery at any point in women.
measure: Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging
time frame: Up to 5 years
description: The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior.
measure: Cascade screening rate among Lynch or HBOC positive carriers
time frame: Up to 5 years
description: Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI).
arm group label: Screening (genetic testing)
arm group type: Other
description: Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of saliva sample
arm group label: Screening (genetic testing)
other name: Biological Sample Collection
intervention type: Other
intervention name: Genetic Counseling
description: Receive genetic counseling if testing results are positive
arm group label: Screening (genetic testing)
intervention type: Other
intervention name: Genetic Testing
description: Undergo genetic testing
arm group label: Screening (genetic testing)
other name: genetic analysis
other name: Genetic Examination
other name: Genetic Test
intervention type: Other
intervention name: Survey Administration
description: Complete a survey
arm group label: Screening (genetic testing)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jackilen Shannon, Ph.D.
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Jackie Shannon
investigator title: Principal Investigator
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal
mesh term: Carcinoma, Intraductal, Noninfiltrating
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Hereditary Breast and Ovarian Cancer Syndrome
mesh term: Carcinoma, Ductal, Breast
mesh term: Neoplastic Syndromes, Hereditary
mesh term: Syndrome