<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/NCT04475640</url>
  </required_header>
  <id_info>
    <org_study_id>19-006717</org_study_id>
    <secondary_id>NCI-2020-04427</secondary_id>
    <secondary_id>19-006717</secondary_id>
    <nct_id>NCT04475640</nct_id>
  </id_info>
  <brief_title>Cancer Genetic Testing in Ethnic Populations</brief_title>
  <official_title>GEMINI - Cancer Genetic Testing in Ethnic Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      This clinical trial examines the integration of cancer genetic testing in various ethnic&#xD;
      populations. Studying individuals and families at risk of cancer may help identify cancer&#xD;
      genes and other persons at risk. The information from this study may provide an opportunity&#xD;
      for cancer risk stratification and individualized screening in these ethnic populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the prevalence of genetic mutations in cancer patients from various ethnic&#xD;
      populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Perform a chart review to assess the impact of genetic testing as part of standard of&#xD;
      oncology care:&#xD;
&#xD;
      Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel&#xD;
      testing.&#xD;
&#xD;
      Ib. Determine differences in germline mutation detection in these patients as compared to&#xD;
      traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for&#xD;
      genetic evaluation.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo collection of blood or saliva sample for genetic testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Anticipated">October 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2023</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>Prevalence of pathogenic germline mutations in enrolled patients within each cancer site</measure>
    <time_frame>Study completion (2 years)</time_frame>
    <description>Will identify the prevalence of pathogenic germline mutations in enrolled patients within each cancer site, age (&lt; 60 years old versus (vs.) &gt;= 60 years old), and stage (early vs. advanced) via descriptive statistics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of positive pathogenic germline mutations</measure>
    <time_frame>Study completion (2 years)</time_frame>
    <description>Will determine whether the prevalence of positive pathogenic germline mutations differs between cancer sites, age of diagnosis, and stage of diagnosis using logistic regression analysis across all cancer site groups and pairwise post-hoc analyses using Tukey's correction for multiple comparisons across pairs of cancer sites and chi-square tests of differences between age and stage groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria</measure>
    <time_frame>Study completion (2 years)</time_frame>
    <description>Will compare the rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria within cancer site, age, and stage using logistic regression and pairwise post-hoc analyses as needed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of germline genetic testing on both therapeutic management and targeted cancer prevention</measure>
    <time_frame>Study completion (2 years)</time_frame>
    <description>Will assess the impact of germline genetic testing on both therapeutic management and targeted cancer prevention in family members using logistic regression and pairwise post-hoc analyses as needed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Carcinoma of Unknown Primary</condition>
  <condition>Central Nervous System Carcinoma</condition>
  <condition>Digestive System Carcinoma</condition>
  <condition>Genitourinary System Carcinoma</condition>
  <condition>Head and Neck Carcinoma</condition>
  <condition>Malignant Brain Neoplasm</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <condition>Malignant Musculoskeletal Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <condition>Skin Carcinoma</condition>
  <arm_group>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo collection of blood or saliva sample for genetic testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood sample</description>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Testing</intervention_name>
    <description>Undergo genetic testing</description>
    <arm_group_label>Screening (biospecimen collection)</arm_group_label>
    <other_name>genetic analysis</other_name>
    <other_name>Genetic Examination</other_name>
    <other_name>Genetic Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years of age&#xD;
&#xD;
          -  Individuals diagnosed with any solid tumor cancer including, but not limited to,&#xD;
             gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system&#xD;
             (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary; and presenting&#xD;
             to Mayo Clinic (MC Arizona or MC Florida) for clinical management/treatment; and&#xD;
             patients receive genetic testing as described above&#xD;
&#xD;
          -  Self-identified as being from various ethnic populations including Hispanic/Latino,&#xD;
             Native American/Alaskan, African American (including of African descent), Asian and&#xD;
             other European populations&#xD;
&#xD;
          -  Blood collection is feasible (health, access and/or tolerability) for requested blood&#xD;
             sample(s)&#xD;
&#xD;
          -  Individuals have agreed to participate and signed the study informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had prior germline genetic testing involving a 40+ gene panel within&#xD;
             the last 24 months at Mayo Clinic and available for review by the research coordinator&#xD;
             at time of consent&#xD;
&#xD;
          -  Past or current history of hematological cancer (including leukemias, multiple&#xD;
             myeloma)&#xD;
&#xD;
          -  All bone marrow transplants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niloy J Samadder</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Niloy J. Samadder, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Jeremy C. Jones, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</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>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Female</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/NCT04475640
org study id: 19-006717
secondary id: NCI-2020-04427
secondary id: 19-006717
nct id: NCT04475640
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial examines the integration of cancer genetic testing in various ethnic
      populations. Studying individuals and families at risk of cancer may help identify cancer
      genes and other persons at risk. The information from this study may provide an opportunity
      for cancer risk stratification and individualized screening in these ethnic populations.
PRIMARY OBJECTIVE:

      I. To determine the prevalence of genetic mutations in cancer patients from various ethnic
      populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.

      SECONDARY OBJECTIVES:

      I. Perform a chart review to assess the impact of genetic testing as part of standard of
      oncology care:

      Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel
      testing.

      Ib. Determine differences in germline mutation detection in these patients as compared to
      traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for
      genetic evaluation.

      OUTLINE:

      Patients undergo collection of blood or saliva sample for genetic testing.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Prevalence of pathogenic germline mutations in enrolled patients within each cancer site
time frame: Study completion (2 years)
description: Will identify the prevalence of pathogenic germline mutations in enrolled patients within each cancer site, age (< 60 years old versus (vs.) >= 60 years old), and stage (early vs. advanced) via descriptive statistics.
measure: Prevalence of positive pathogenic germline mutations
time frame: Study completion (2 years)
description: Will determine whether the prevalence of positive pathogenic germline mutations differs between cancer sites, age of diagnosis, and stage of diagnosis using logistic regression analysis across all cancer site groups and pairwise post-hoc analyses using Tukey's correction for multiple comparisons across pairs of cancer sites and chi-square tests of differences between age and stage groups.
measure: Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria
time frame: Study completion (2 years)
description: Will compare the rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria within cancer site, age, and stage using logistic regression and pairwise post-hoc analyses as needed.
measure: Impact of germline genetic testing on both therapeutic management and targeted cancer prevention
time frame: Study completion (2 years)
description: Will assess the impact of germline genetic testing on both therapeutic management and targeted cancer prevention in family members using logistic regression and pairwise post-hoc analyses as needed.
arm group label: Screening (biospecimen collection)
arm group type: Experimental
description: Patients undergo collection of blood or saliva sample for genetic testing.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood sample
arm group label: Screening (biospecimen collection)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Other
intervention name: Genetic Testing
description: Undergo genetic testing
arm group label: Screening (biospecimen collection)
other name: genetic analysis
other name: Genetic Examination
other name: Genetic Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Niloy J Samadder
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Brain Neoplasms
mesh term: Genital Neoplasms, Female