<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/NCT04500301</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00081754</org_study_id>
    <secondary_id>Pro00045081</secondary_id>
    <secondary_id>LCI-SUPP-NOS-PGX-001</secondary_id>
    <nct_id>NCT04500301</nct_id>
  </id_info>
  <brief_title>Pharmacogenomic Testing to Personalize Supportive Oncology</brief_title>
  <official_title>Evaluating the Use of Preemptive Pharmacogenomic Testing to Personalize Supportive Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to evaluate pharmacogenomics (PGx) guided drug prescribing for&#xD;
      pain and depression in patients with cancer. The investigators aim to understand how PGx&#xD;
      testing can be used to improve medication management for pain and depression, and whether&#xD;
      PGx-guided prescribing improves these symptoms and quality of life compared to historical&#xD;
      controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective clinical trial of adult cancer patients presenting with pain and&#xD;
      depression, newly referred to the Department of Supportive Oncology, and receiving preemptive&#xD;
      PGx testing for genes related to supportive care prior to the first clinic visit. Genotyping&#xD;
      results will be returned within approximately 4-5 business days. A PGx specialist will&#xD;
      provide detailed clinical interpretations to the referring provider and upload a copy of the&#xD;
      test results into the subject's medical chart. A consultation note will also be placed in&#xD;
      each subject's chart detailing the PGx results. Supportive Oncology clinicians will be&#xD;
      instructed to consult a pharmacist to evaluate PGx test results prior to prescribing&#xD;
      supportive care therapies, especially pain and depression medications. The number of consults&#xD;
      and recommendations will be documented, in addition to test results, demographic data,&#xD;
      medical/medication history, ESAS symptom scores, PHQ9 depression scores, and side effects of&#xD;
      supportive therapy. The number of ambulatory clinic visits and hospitalizations will be used&#xD;
      to estimate health care utilization and costs. Subjects will complete a short survey at the&#xD;
      end of the study period regarding their knowledge about PGx, and whether access to PGx&#xD;
      information improves satisfaction with care and communication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Utilization of PGx results</measure>
    <time_frame>21, 42, 63 and 84 days after the baseline visit</time_frame>
    <description>Estimate the proportions of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on PGx test results within any of the study visits after the Baseline study visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scores Impact</measure>
    <time_frame>21, 42, 63 and 84 days after the baseline visit</time_frame>
    <description>Determine the impact of PGx on treatment outcomes by measuring pain scores on a scale of 0-10 (0 no pain, 10 worst possible severity) using the Edmonton Symptom Assessment Scale (ESAS) at study visits after the Baseline study visit. Symptom scores will also be compared between those receiving PGx testing and a matched control receiving clinical management alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Scores Impact</measure>
    <time_frame>21, 42, 63 and 84 days after the baseline visit</time_frame>
    <description>Determine the impact of PGx on treatment outcomes by measuring depression on a scale of 0-27 (0 no depression, 27 severe depression) using the Patient Health Questionnaire 9 (PHQ9) at study visits after the Baseline study visit. Symptom scores will also be compared between those receiving PGx testing and a matched control receiving clinical management alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Health Care Utilization</measure>
    <time_frame>84 days</time_frame>
    <description>Compare health care utilization (HCRU) using cost in USD, including but not limited to cost associated with inpatient, emergency department, outpatient, and pharmacy encounters between subjects receiving PGx testing and matched controls receiving clinical management alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Perspectives</measure>
    <time_frame>Assessed at the final study visit (day 84)</time_frame>
    <description>Describe subject perspectives of PGx testing using a survey administered to subjects after/at the Final visit (or sooner if withdrawn).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Frequency of Actionable Genotypes</measure>
    <time_frame>84 days</time_frame>
    <description>Determine the frequencies of actionable genotypes that result in drug/dose selection or modification(s) during the study period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Types of New Medications Prescribed</measure>
    <time_frame>84 days</time_frame>
    <description>Describe the types of new medications prescribed or medication/dose adjustments based on the PGx results.</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of Drug/Gene Interactions</measure>
    <time_frame>Baseline (day 0) and day 84</time_frame>
    <description>Determine the frequency of drug/gene interactions present at the Baseline and the Final study visit using CPIC guidelines and FDA's pharmacogenomics table.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Cancer</condition>
  <condition>Depression</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Pharmacogenomic Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preemptive Pharmacogenomic Testing</intervention_name>
    <description>The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.</description>
    <arm_group_label>Pharmacogenomic Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Written informed consent and HIPAA authorization for release of personal health&#xD;
             information.&#xD;
&#xD;
          -  Completion of ESAS at initial palliative medicine clinic visit, presenting with&#xD;
             moderate to high pain (≥ 4/10) and/or depression (≥ 3/10).&#xD;
&#xD;
          -  New patients ≥ 18 years of age who have had an initial visit in the Department of&#xD;
             Supportive Oncology's palliative medicine clinic with hematologic malignancy or any&#xD;
             stage solid tumor malignancy according to the provider.&#xD;
&#xD;
          -  Agree to at least one additional palliative medicine clinic visit per protocol.&#xD;
&#xD;
          -  Able to provide a buccal sample for PGx testing.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Psychiatric illness, social situations, or active/recent (within 30 days) history of&#xD;
             illicit substance (e.g. cocaine, heroin) abuse that would limit compliance with study&#xD;
             requirements (e.g. clinic visits, medication compliance, etc.) as determined by the&#xD;
             Investigator.&#xD;
&#xD;
          -  Patients who have had prior multiple visits in palliative medicine clinic.&#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>Jai Patel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 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>Depression</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 16, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT04500301/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04500301
org study id: IRB00081754
secondary id: Pro00045081
secondary id: LCI-SUPP-NOS-PGX-001
nct id: NCT04500301
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate pharmacogenomics (PGx) guided drug prescribing for
      pain and depression in patients with cancer. The investigators aim to understand how PGx
      testing can be used to improve medication management for pain and depression, and whether
      PGx-guided prescribing improves these symptoms and quality of life compared to historical
      controls.
This is a prospective clinical trial of adult cancer patients presenting with pain and
      depression, newly referred to the Department of Supportive Oncology, and receiving preemptive
      PGx testing for genes related to supportive care prior to the first clinic visit. Genotyping
      results will be returned within approximately 4-5 business days. A PGx specialist will
      provide detailed clinical interpretations to the referring provider and upload a copy of the
      test results into the subject's medical chart. A consultation note will also be placed in
      each subject's chart detailing the PGx results. Supportive Oncology clinicians will be
      instructed to consult a pharmacist to evaluate PGx test results prior to prescribing
      supportive care therapies, especially pain and depression medications. The number of consults
      and recommendations will be documented, in addition to test results, demographic data,
      medical/medication history, ESAS symptom scores, PHQ9 depression scores, and side effects of
      supportive therapy. The number of ambulatory clinic visits and hospitalizations will be used
      to estimate health care utilization and costs. Subjects will complete a short survey at the
      end of the study period regarding their knowledge about PGx, and whether access to PGx
      information improves satisfaction with care and communication.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Utilization of PGx results
time frame: 21, 42, 63 and 84 days after the baseline visit
description: Estimate the proportions of subjects undergoing PGx testing who receive at least one drug/dose selection or modification based on PGx test results within any of the study visits after the Baseline study visit.
measure: Pain Scores Impact
time frame: 21, 42, 63 and 84 days after the baseline visit
description: Determine the impact of PGx on treatment outcomes by measuring pain scores on a scale of 0-10 (0 no pain, 10 worst possible severity) using the Edmonton Symptom Assessment Scale (ESAS) at study visits after the Baseline study visit. Symptom scores will also be compared between those receiving PGx testing and a matched control receiving clinical management alone.
measure: Depression Scores Impact
time frame: 21, 42, 63 and 84 days after the baseline visit
description: Determine the impact of PGx on treatment outcomes by measuring depression on a scale of 0-27 (0 no depression, 27 severe depression) using the Patient Health Questionnaire 9 (PHQ9) at study visits after the Baseline study visit. Symptom scores will also be compared between those receiving PGx testing and a matched control receiving clinical management alone.
measure: Compare Health Care Utilization
time frame: 84 days
description: Compare health care utilization (HCRU) using cost in USD, including but not limited to cost associated with inpatient, emergency department, outpatient, and pharmacy encounters between subjects receiving PGx testing and matched controls receiving clinical management alone.
measure: Subject Perspectives
time frame: Assessed at the final study visit (day 84)
description: Describe subject perspectives of PGx testing using a survey administered to subjects after/at the Final visit (or sooner if withdrawn).
measure: Frequency of Actionable Genotypes
time frame: 84 days
description: Determine the frequencies of actionable genotypes that result in drug/dose selection or modification(s) during the study period.
measure: Types of New Medications Prescribed
time frame: 84 days
description: Describe the types of new medications prescribed or medication/dose adjustments based on the PGx results.
measure: Frequency of Drug/Gene Interactions
time frame: Baseline (day 0) and day 84
description: Determine the frequency of drug/gene interactions present at the Baseline and the Final study visit using CPIC guidelines and FDA's pharmacogenomics table.
arm group label: Pharmacogenomic Testing
arm group type: Experimental
description: A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response.
intervention type: Other
intervention name: Preemptive Pharmacogenomic Testing
description: The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.
arm group label: Pharmacogenomic Testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jai Patel, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
provided document: 