<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/NCT04504604</url>
  </required_header>
  <id_info>
    <org_study_id>TCF-001</org_study_id>
    <nct_id>NCT04504604</nct_id>
  </id_info>
  <brief_title>TCF-001 TRACK (Target Rare Cancer Knowledge) Study</brief_title>
  <acronym>TRACK</acronym>
  <official_title>TCF-001 TRACK (Target Rare Cancer Knowledge) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TargetCancer Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Foundation Medicine</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>TargetCancer Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open label, non-randomized, multi-center, pragmatic study aims to establish whether&#xD;
      patients with rare tumors can benefit from matched molecular therapy as dictated by their&#xD;
      next-generation sequencing (NGS) results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This open label, non-randomized, multi-center, pragmatic study aims to establish whether&#xD;
      patients with rare tumors can benefit from matched molecular therapy as dictated by their&#xD;
      next-generation sequencing (NGS) results. The study leverages a remote consent and&#xD;
      participation approach to open enrollment to all patients with rare tumors within the United&#xD;
      States. Traditional, site-based patient consenting and participation is also available for&#xD;
      enrollment to the study.&#xD;
&#xD;
      Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine&#xD;
      Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating&#xD;
      cell-free DNA may be additionally collected for repeat CGP at various timepoints during the&#xD;
      study.&#xD;
&#xD;
      The CGP findings will be provided by FMI directly to the treating physician and study sponsor&#xD;
      TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual&#xD;
      Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report&#xD;
      to the treating physician on recommended treatments and/or relevant clinical trials; the&#xD;
      treating physician makes all treatment decisions. The resultant treatments and treatment&#xD;
      responses will be tracked longitudinally during the term of this study, thus linking&#xD;
      molecularly informed treatments to specific patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.</measure>
    <time_frame>2 years</time_frame>
    <description>The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.</measure>
    <time_frame>2 years</time_frame>
    <description>The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Tumor Biomarker Profiling to Treatment Outcome.</measure>
    <time_frame>2 years</time_frame>
    <description>Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)&gt;6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Rare Cancers</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Cancer of Unknown Primary Site</condition>
  <arm_group>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible patients that present with Cholangiocarcinoma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cancer of Unknown Primary (CUP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible patients with cancer of unknown primary site (CUP).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other remaining rare cancers (solid tumors &amp; lymphomas)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FoundationOne CDx and FoundationOne Liquid CDx</intervention_name>
    <description>Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.</description>
    <arm_group_label>Cancer of Unknown Primary (CUP)</arm_group_label>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_label>Other remaining rare cancers (solid tumors &amp; lymphomas)</arm_group_label>
    <other_name>FoundationOne CDx</other_name>
    <other_name>FoundationOne Liquid CDx</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Provision of signed and dated informed consent form.&#xD;
&#xD;
          -  Stated willingness to comply with all study related blood draws and assessments for&#xD;
             the duration of the study.&#xD;
&#xD;
          -  Individuals who are 18 years old or older at the time of consent.&#xD;
&#xD;
          -  Patients with a rare (fewer than 6 cases per 100,000 per year) solid tumor or lymphoma&#xD;
             with evaluable disease at baseline. The complete list of included cancers are included&#xD;
             in the study protocol; diseases not listed in the study protocol may be enrolled with&#xD;
             the approval of the Principal Investigator.&#xD;
&#xD;
          -  May or may not have had qualifying (by Foundation Medicine) comprehensive genomic&#xD;
             profiling before the present study. For those who have had qualifying comprehensive&#xD;
             genomic profiling performed prior to the present study, the archival specimen tested&#xD;
             must have been harvested within 18 months of the baseline visit (i.e. date of consent)&#xD;
             of the present study.&#xD;
&#xD;
          -  Willingness to provide existing archived and/or newly collected tissue resulting from&#xD;
             standard of care procedures and blood samples for genomic profiling. If the submitted&#xD;
             sample is determined to be insufficient for testing, the patient will be considered to&#xD;
             be a screen failure.&#xD;
&#xD;
          -  For archival tissue to be used for comprehensive genomic profiling for the present&#xD;
             study, that specimen must have been harvested within 18 months of the baseline visit&#xD;
             (i.e. date of consent) of the present study.&#xD;
&#xD;
          -  Willingness to provide clinical and medical information to the study team as required.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.&#xD;
&#xD;
          -  Ability to read, write and communicate in English.&#xD;
&#xD;
          -  Ability to review and sign a web-based informed consent form, or review and sign an&#xD;
             informed consent form in treating physician office.&#xD;
&#xD;
          -  Resides within the United States.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Participants who are unable to provide informed consent.&#xD;
&#xD;
          -  Participants who are 17 years of age or younger.&#xD;
&#xD;
          -  Participants who are unable to comply with the study procedures.&#xD;
&#xD;
          -  Known existence of an uncontrolled intercurrent illness including, but not limited to,&#xD;
             psychiatric illness or social situations that would impair compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  Concurrent active malignancy requiring treatment within 1 year of enrollment, at the&#xD;
             discretion of treating physician.&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  Any unlisted criteria at the discretion of the treating physician.&#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>Razelle Kurzrock, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vivek Subbiah, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas MD Anderson Cancer Center (MDACC)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shumei Kato, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary Oster</last_name>
    <phone>617-299-0389</phone>
    <email>mary@targetcancerfoundation.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>TargetCancer Foundation</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02139</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Oster</last_name>
      <phone>617-299-0389</phone>
      <email>Mary@targetcancerfoundation.org</email>
    </contact>
    <investigator>
      <last_name>Shumei Kato, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.targetcancerfoundation.org/track</url>
    <description>Study information</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>genomics</keyword>
  <keyword>precision medicine</keyword>
  <keyword>molecular tumor board</keyword>
  <keyword>remote participation</keyword>
  <keyword>targeted therapy</keyword>
  <keyword>patient reported outcomes</keyword>
  <keyword>understudied diseases</keyword>
  <keyword>comprehensive genomic profiling</keyword>
  <keyword>virtual</keyword>
  <keyword>next generation sequencing</keyword>
  <keyword>liquid biopsies</keyword>
  <keyword>tumor biopsies</keyword>
  <keyword>cell-free DNA</keyword>
  <keyword>biomarker testing</keyword>
  <keyword>solid tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
    <mesh_term>Neoplasms, Unknown Primary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04504604
org study id: TCF-001
nct id: NCT04504604
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This open label, non-randomized, multi-center, pragmatic study aims to establish whether
      patients with rare tumors can benefit from matched molecular therapy as dictated by their
      next-generation sequencing (NGS) results.
This open label, non-randomized, multi-center, pragmatic study aims to establish whether
      patients with rare tumors can benefit from matched molecular therapy as dictated by their
      next-generation sequencing (NGS) results. The study leverages a remote consent and
      participation approach to open enrollment to all patients with rare tumors within the United
      States. Traditional, site-based patient consenting and participation is also available for
      enrollment to the study.

      Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine
      Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating
      cell-free DNA may be additionally collected for repeat CGP at various timepoints during the
      study.

      The CGP findings will be provided by FMI directly to the treating physician and study sponsor
      TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual
      Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report
      to the treating physician on recommended treatments and/or relevant clinical trials; the
      treating physician makes all treatment decisions. The resultant treatments and treatment
      responses will be tracked longitudinally during the term of this study, thus linking
      molecularly informed treatments to specific patient outcomes.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB.
time frame: 2 years
description: The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.
measure: Progression-free survival (PFS) among participants who received the molecularly targeted matched treatment.
time frame: 2 years
description: The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.
measure: Comparison of Tumor Biomarker Profiling to Treatment Outcome.
time frame: 2 years
description: Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).
arm group label: Cholangiocarcinoma
arm group type: Active Comparator
description: Eligible patients that present with Cholangiocarcinoma.
arm group label: Cancer of Unknown Primary (CUP)
arm group type: Active Comparator
description: Eligible patients with cancer of unknown primary site (CUP).
arm group label: Other remaining rare cancers (solid tumors & lymphomas)
arm group type: Active Comparator
description: Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).
intervention type: Diagnostic Test
intervention name: FoundationOne CDx and FoundationOne Liquid CDx
description: Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.
arm group label: Cancer of Unknown Primary (CUP)
arm group label: Cholangiocarcinoma
arm group label: Other remaining rare cancers (solid tumors & lymphomas)
other name: FoundationOne CDx
other name: FoundationOne Liquid CDx
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Razelle Kurzrock, M.D.
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Vivek Subbiah, M.D.
role: Principal Investigator
affiliation: The University of Texas MD Anderson Cancer Center (MDACC)
last name: Shumei Kato, M.D.
role: Principal Investigator
affiliation: University of California, San Diego
last name: Mary Oster
phone: 617-299-0389
email: mary@targetcancerfoundation.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: https://www.targetcancerfoundation.org/track
description: Study information
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Neoplasms, Unknown Primary
sharing ipd: No