<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/NCT04456140</url>
  </required_header>
  <id_info>
    <org_study_id>19-011472</org_study_id>
    <secondary_id>NCI-2020-04429</secondary_id>
    <secondary_id>19-011472</secondary_id>
    <nct_id>NCT04456140</nct_id>
  </id_info>
  <brief_title>Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study</brief_title>
  <official_title>Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 phase I trial collects blood samples to investigate the prevalence of changes in genes&#xD;
      (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded&#xD;
      Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or&#xD;
      treat others who have genetic mutations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the prevalence of genetic mutations in cancer patients seeking care at the&#xD;
      Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida.&#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 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;
      Ib. Determine the percentage of relatives of mutation positive probands undergoing family&#xD;
      variant testing within a 3 month window of return of testing results.&#xD;
&#xD;
      Ic. Assess patient experience and barriers to care with a genetic service line via survey&#xD;
      measures.&#xD;
&#xD;
      Id. Develop a biorepository of samples (blood) from cancer patients participating in this&#xD;
      protocol.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients watch a pre-recorded genetic counseling video and those who consent to genetic&#xD;
      testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes&#xD;
      each prior to receiving their genetic test results and following the receipt of genetic test&#xD;
      results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">September 21, 2021</completion_date>
  <primary_completion_date type="Actual">September 21, 2021</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of pathogenic germline mutations</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be assessed by 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>Difference between prevalence of positive pathogenic germline mutations</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be assessed by 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</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Will be compared 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>Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Assessed using logistic regression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Assessed using pairwise post-hoc analyses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in survey responses between patient groups</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Patients will be grouped by genetic test result (positive vs. negative), age (&lt; 60 years old vs. &gt;= 60 years old), stage (early vs. advanced), and over time (enrollment vs. after test results are received).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Digestive System Neoplasm</condition>
  <condition>Malignant Brain Neoplasm</condition>
  <condition>Malignant Central Nervous System Neoplasm</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <condition>Malignant Genitourinary System Neoplasm</condition>
  <condition>Malignant Head and Neck Neoplasm</condition>
  <condition>Malignant Musculoskeletal Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <condition>Metastatic Malignant Neoplasm of Unknown Primary</condition>
  <condition>Skin Carcinoma</condition>
  <arm_group>
    <arm_group_label>Prevention (pre-genetic test counseling, genetic testing)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood samples</description>
    <arm_group_label>Prevention (pre-genetic test counseling, genetic testing)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic Counseling</intervention_name>
    <description>Watch pre-test genetic counseling video</description>
    <arm_group_label>Prevention (pre-genetic test counseling, 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>Prevention (pre-genetic test counseling, 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>Ancillary studies</description>
    <arm_group_label>Prevention (pre-genetic test counseling, genetic testing)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals diagnosed with any solid tumor cancer (stages 1-4) including, but not&#xD;
             limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central&#xD;
             nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary&#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;
          -  Individuals who do not meet study inclusion criteria&#xD;
&#xD;
          -  Individuals with an active hematologic malignancy&#xD;
&#xD;
          -  Patients who have had prior germline genetic testing involving a 40+ gene panel within&#xD;
             the last 24 months at Mayo Clinic or St Vincent's Healthcare and available for review&#xD;
             by the research coordinator at time of consent&#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>
  </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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Niloy Jewel (Jewel) Samadder</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>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Nervous System Neoplasms</mesh_term>
    <mesh_term>Central Nervous System Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Female</mesh_term>
    <mesh_term>Neoplasms, Unknown Primary</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/NCT04456140
org study id: 19-011472
secondary id: NCI-2020-04429
secondary id: 19-011472
nct id: NCT04456140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase I trial collects blood samples to investigate the prevalence of changes in genes
      (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded
      Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or
      treat others who have genetic mutations.
PRIMARY OBJECTIVE:

      I. To determine the prevalence of genetic mutations in cancer patients seeking care at the
      Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida.

      SECONDARY OBJECTIVES:

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

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

      Ib. Determine the percentage of relatives of mutation positive probands undergoing family
      variant testing within a 3 month window of return of testing results.

      Ic. Assess patient experience and barriers to care with a genetic service line via survey
      measures.

      Id. Develop a biorepository of samples (blood) from cancer patients participating in this
      protocol.

      OUTLINE:

      Patients watch a pre-recorded genetic counseling video and those who consent to genetic
      testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes
      each prior to receiving their genetic test results and following the receipt of genetic test
      results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Prevalence of pathogenic germline mutations
time frame: Up to 3 months
description: Will be assessed by each cancer site, age (< 60 years old versus [vs.] >= 60 years old), and stage (early vs. advanced) via descriptive statistics.
measure: Difference between prevalence of positive pathogenic germline mutations
time frame: Up to 3 months
description: Will be assessed by 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
time frame: Up to 3 months
description: Will be compared 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: Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
time frame: Up to 3 months
description: Assessed using logistic regression
measure: Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
time frame: Up to 3 months
description: Assessed using pairwise post-hoc analyses
measure: Differences in survey responses between patient groups
time frame: Up to 3 months
description: Patients will be grouped by genetic test result (positive vs. negative), age (< 60 years old vs. >= 60 years old), stage (early vs. advanced), and over time (enrollment vs. after test results are received).
arm group label: Prevention (pre-genetic test counseling, genetic testing)
arm group type: Experimental
description: Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood samples
arm group label: Prevention (pre-genetic test counseling, genetic testing)
intervention type: Other
intervention name: Genetic Counseling
description: Watch pre-test genetic counseling video
arm group label: Prevention (pre-genetic test counseling, genetic testing)
intervention type: Other
intervention name: Genetic Testing
description: Undergo genetic testing
arm group label: Prevention (pre-genetic test counseling, genetic testing)
other name: genetic analysis
other name: Genetic Examination
other name: Genetic Test
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Prevention (pre-genetic test counseling, genetic testing)
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: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Niloy Jewel (Jewel) Samadder
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Brain Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Nervous System Neoplasms
mesh term: Central Nervous System Neoplasms
mesh term: Genital Neoplasms, Female
mesh term: Neoplasms, Unknown Primary