<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/NCT03804255</url>
  </required_header>
  <id_info>
    <org_study_id>EAQ161CD</org_study_id>
    <secondary_id>NCI-2018-01707</secondary_id>
    <secondary_id>EAQ161CD</secondary_id>
    <secondary_id>ECOG-ACRIN-EAQ161CD</secondary_id>
    <secondary_id>EAQ161CD</secondary_id>
    <secondary_id>UG1CA189828</secondary_id>
    <nct_id>NCT03804255</nct_id>
  </id_info>
  <brief_title>Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting</brief_title>
  <official_title>Biomarker Testing in Common Solid Cancers: An Assessment of Current Practices in Precision Oncology in the Community Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ECOG-ACRIN Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Cooperative Oncology Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial assesses current biomarker testing practices for common solid cancers in precision&#xD;
      oncology in the community setting. Cancer biomarkers are used for diagnosing the disease,&#xD;
      determining prognosis, predicting response to a targeted therapy, or monitoring response to&#xD;
      therapy. Testing quality, including accuracy and timeliness, is imperative for correct&#xD;
      disease prognosis and identification of patients who may or may not benefit from a targeted&#xD;
      therapy. Assessing current biomarker testing practices may help doctors identify gaps and&#xD;
      variations in testing as well as on potential ?best practices? that may be informative and&#xD;
      generalizable to community oncology programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine capacity of pathology practices within National Cancer Institute (NCI) Community&#xD;
      Oncology Research Program (NCORP) components/subcomponents for testing guideline-recommended&#xD;
      biomarkers, including whether these biomarkers are tested, and how, i.e. what technologies&#xD;
      are used and what ordering and testing processes / protocols have been implemented.&#xD;
&#xD;
      II. Determine capacity for testing for novel biomarkers and tumor molecular profiling, i.e.&#xD;
      whether these biomarkers are tested and how, i.e. what technologies are used what ordering&#xD;
      and testing processes/protocols have been implemented.&#xD;
&#xD;
      III. For findings in Objectives 1 and 2, determine factors influencing the heterogeneity of&#xD;
      capacity for biomarker testing, particularly those factors that are modifiable (based on the&#xD;
      conceptual framework above), such as cost, complexity, technologic complexity, lack of&#xD;
      familiarity, physician and patient demand.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants complete a self-administered web-based Biomarker Survey and may also complete an&#xD;
      Outcome Validation Survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study closed before patients enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">May 29, 2020</completion_date>
  <primary_completion_date type="Actual">May 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of reflexive testing protocols for guideline-recommended biomarkers</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Defined as standing protocols that do not require an oncologist order for each of the following: 1) EGFR and ALK testing in lung cancer; 2) KRAS testing in colorectal cancer; 3) BRAF testing in melanoma; and 4) HER2 testing in breast cancer. Will itemize each guideline recommendation and determine whether each pathology practice has reflexive testing protocols through self-report on the assessment. The proportion of pathology practices and exact 95% two-sided confidence intervals with reflexive-testing protocols will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The pathology practices will indicate the average number of business days between the day the tumor tissue is available and the day that all the test results are reported to the physician. Pathology practices will be considered meeting guidelines if the average is less than or equal to 10 days. The proportion of pathology practices and exact 95% two-sided confidence intervals with average turnaround time within 10 business days will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors influencing heterogeneity of capacity for biomarker testing, from among modifiable testing practice-related factors, e.g. cost, complexity, technologic complexity, lack of familiarity, physician and patient demand</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>For each biomarker-cancer combination being investigated, univariate and multivariate logistic regression modelling will be performed. There will be variables collected at the oncology component/subcomponent level and variables collected at the pathology practice level. The analysis will be completed at the level of the pathology practice, so characteristics of the oncology component/subcomponent will have to be adapted to that of the pathology practice: repeated for all of pathology practices used by one oncology component/subcomponent, or consolidated for pathology practices that service multiple oncology component/subcomponent. Variables used to assess heterogeneity will be (a) component/subcomponent characteristics: geography (census region), size (number of adult oncology beds), safety-net hospital, minority/underserved National Cancer Institute (NCI) Community Oncology Research Program (NCORP) component/subcomponent, academic hospital, public-ownership type.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of genotyping or broad molecular profiling/next generation tumor sequencing for EGFR and ALK testing in lung cancer</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Will determine whether each pathology practice is using genotyping or broad molecular profiling / next-generation tumor sequencing through self reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of MMR protein expression testing by immunohistochemistry (IHC) or microsatellite instability (MSI) in colorectal cancer</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>For colorectal cancer, will determine whether each pathology practice is using MMR protein expression testing by IHC or MSI through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Capacity to test for cMET or PTEN in lung cancer</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Will determine whether each pathology practice has the capacity to test for cMET or PTEN through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>For colorectal cancer, will determine whether each pathology practice has the capacity to test for HRAS, AKT1, PTEN or PIK3CA through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>For novel biomarkers, will determine whether each pathology practice tests for novel biomarkers to be used for clinical care, clinical trials, or both through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each time point will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days between sample availability and report availability for all biomarkers tested</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Each pathology practice will report the number of days until all biomarkers tested are completed. The average number of days across all pathology practices and 95% two-sided confidence intervals will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of pathology practices testing for novel biomarkers using a standard reflexive testing protocol</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Will determine whether each pathology practice tests for novel biomarkers using a standard reflexive testing protocol through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each characteristic will be calculated.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Colorectal Carcinoma</condition>
  <condition>Community Practice</condition>
  <condition>Lung Carcinoma</condition>
  <condition>Melanoma</condition>
  <condition>Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Observational (survey)</arm_group_label>
    <description>Participants complete a self-administered web-based Biomarker Survey and may also complete an Outcome Validation Survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Complete surveys</description>
    <arm_group_label>Observational (survey)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Onsite pathology practices within NCORP components and subcomponents that provide services&#xD;
        to adult oncology groups&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study population is all onsite pathology practices within NCORP components and&#xD;
             subcomponents that provide services to adult oncology groups.&#xD;
&#xD;
          -  An onsite pathology practice is a laboratory (lab) that is financially administered&#xD;
             and operated by an NCORP component or subcomponent. This excludes commercial reference&#xD;
             laboratories, such as Quest and LabCorp. To describe biomarker testing practices&#xD;
             across NCORP components/subcomponents, we will use the pathology practice as the unit&#xD;
             of analysis. Participating components/subcomponents should meet [element A] AND [at&#xD;
             least one element of B OR C OR D] AND element E.&#xD;
&#xD;
               -  A) NCORP component/subcomponent provides services to adult oncology groups.&#xD;
&#xD;
               -  B) A single onsite pathology lab (and its set of testing practices), may provide&#xD;
                  biomarker/pathology testing services to one or more components or subcomponents.&#xD;
                  Irrespective of the number of components/subcomponents that use this pathology&#xD;
                  lab, we will consider this as one pathology practice, and one unit of analysis.&#xD;
&#xD;
               -  C) Several onsite pathology labs may provide services to one NCORP component or&#xD;
                  subcomponent, e.g. if the NCORP component or subcomponent represents a health&#xD;
                  system with several hospitals, and each hospital may have its own onsite&#xD;
                  pathology lab, with each pathology lab following its own set of testing&#xD;
                  practices. Therefore, each lab will represent one pathology practice and one unit&#xD;
                  of analysis.&#xD;
&#xD;
               -  D) More than one onsite pathology lab may use a common set of testing practices&#xD;
                  and provide services to one or more NCORP components or subcomponents. Given&#xD;
                  common testing practices, we will consider these labs as one pathology practice,&#xD;
                  and one unit of analysis.&#xD;
&#xD;
               -  E) The pathology practice has an informed individual who is willing to serve as a&#xD;
                  representative and gather information to complete the assessment items. This&#xD;
                  person typically is the pathology practice medical director, pathology practice&#xD;
                  administrative director and/or their designees.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Trosman</last_name>
    <role>Principal Investigator</role>
    <affiliation>ECOG-ACRIN Cancer Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Business Models in Healthcare</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60625</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>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>July 23, 2023</last_update_submitted>
  <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 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>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</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/NCT03804255
org study id: EAQ161CD
secondary id: NCI-2018-01707
secondary id: EAQ161CD
secondary id: ECOG-ACRIN-EAQ161CD
secondary id: EAQ161CD
secondary id: UG1CA189828
nct id: NCT03804255
lead sponsor: 
collaborator: 
has dmc: Yes
This trial assesses current biomarker testing practices for common solid cancers in precision
      oncology in the community setting. Cancer biomarkers are used for diagnosing the disease,
      determining prognosis, predicting response to a targeted therapy, or monitoring response to
      therapy. Testing quality, including accuracy and timeliness, is imperative for correct
      disease prognosis and identification of patients who may or may not benefit from a targeted
      therapy. Assessing current biomarker testing practices may help doctors identify gaps and
      variations in testing as well as on potential ?best practices? that may be informative and
      generalizable to community oncology programs.
PRIMARY OBJECTIVES:

      I. Determine capacity of pathology practices within National Cancer Institute (NCI) Community
      Oncology Research Program (NCORP) components/subcomponents for testing guideline-recommended
      biomarkers, including whether these biomarkers are tested, and how, i.e. what technologies
      are used and what ordering and testing processes / protocols have been implemented.

      II. Determine capacity for testing for novel biomarkers and tumor molecular profiling, i.e.
      whether these biomarkers are tested and how, i.e. what technologies are used what ordering
      and testing processes/protocols have been implemented.

      III. For findings in Objectives 1 and 2, determine factors influencing the heterogeneity of
      capacity for biomarker testing, particularly those factors that are modifiable (based on the
      conceptual framework above), such as cost, complexity, technologic complexity, lack of
      familiarity, physician and patient demand.

      OUTLINE:

      Participants complete a self-administered web-based Biomarker Survey and may also complete an
      Outcome Validation Survey.
observational model: Ecologic or Community
time perspective: Prospective
measure: Presence of reflexive testing protocols for guideline-recommended biomarkers
time frame: Up to 9 months
description: Defined as standing protocols that do not require an oncologist order for each of the following: 1) EGFR and ALK testing in lung cancer; 2) KRAS testing in colorectal cancer; 3) BRAF testing in melanoma; and 4) HER2 testing in breast cancer. Will itemize each guideline recommendation and determine whether each pathology practice has reflexive testing protocols through self-report on the assessment. The proportion of pathology practices and exact 95% two-sided confidence intervals with reflexive-testing protocols will be calculated.
measure: Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer
time frame: Up to 9 months
description: The pathology practices will indicate the average number of business days between the day the tumor tissue is available and the day that all the test results are reported to the physician. Pathology practices will be considered meeting guidelines if the average is less than or equal to 10 days. The proportion of pathology practices and exact 95% two-sided confidence intervals with average turnaround time within 10 business days will be calculated.
measure: Factors influencing heterogeneity of capacity for biomarker testing, from among modifiable testing practice-related factors, e.g. cost, complexity, technologic complexity, lack of familiarity, physician and patient demand
time frame: Up to 9 months
description: For each biomarker-cancer combination being investigated, univariate and multivariate logistic regression modelling will be performed. There will be variables collected at the oncology component/subcomponent level and variables collected at the pathology practice level. The analysis will be completed at the level of the pathology practice, so characteristics of the oncology component/subcomponent will have to be adapted to that of the pathology practice: repeated for all of pathology practices used by one oncology component/subcomponent, or consolidated for pathology practices that service multiple oncology component/subcomponent. Variables used to assess heterogeneity will be (a) component/subcomponent characteristics: geography (census region), size (number of adult oncology beds), safety-net hospital, minority/underserved National Cancer Institute (NCI) Community Oncology Research Program (NCORP) component/subcomponent, academic hospital, public-ownership type.
measure: Use of genotyping or broad molecular profiling/next generation tumor sequencing for EGFR and ALK testing in lung cancer
time frame: Up to 9 months
description: Will determine whether each pathology practice is using genotyping or broad molecular profiling / next-generation tumor sequencing through self reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.
measure: Use of MMR protein expression testing by immunohistochemistry (IHC) or microsatellite instability (MSI) in colorectal cancer
time frame: Up to 9 months
description: For colorectal cancer, will determine whether each pathology practice is using MMR protein expression testing by IHC or MSI through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.
measure: Capacity to test for cMET or PTEN in lung cancer
time frame: Up to 9 months
description: Will determine whether each pathology practice has the capacity to test for cMET or PTEN through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.
measure: Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer
time frame: Up to 9 months
description: For colorectal cancer, will determine whether each pathology practice has the capacity to test for HRAS, AKT1, PTEN or PIK3CA through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.
measure: Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)
time frame: Up to 9 months
description: For novel biomarkers, will determine whether each pathology practice tests for novel biomarkers to be used for clinical care, clinical trials, or both through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each time point will be calculated.
measure: Number of days between sample availability and report availability for all biomarkers tested
time frame: Up to 9 months
description: Each pathology practice will report the number of days until all biomarkers tested are completed. The average number of days across all pathology practices and 95% two-sided confidence intervals will be calculated.
measure: Proportion of pathology practices testing for novel biomarkers using a standard reflexive testing protocol
time frame: Up to 9 months
description: Will determine whether each pathology practice tests for novel biomarkers using a standard reflexive testing protocol through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each characteristic will be calculated.
arm group label: Observational (survey)
description: Participants complete a self-administered web-based Biomarker Survey and may also complete an Outcome Validation Survey.
intervention type: Other
intervention name: Survey Administration
description: Complete surveys
arm group label: Observational (survey)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Trosman
role: Principal Investigator
affiliation: ECOG-ACRIN Cancer Research Group
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms