<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/NCT01703585</url>
  </required_header>
  <id_info>
    <org_study_id>MATCH-001</org_study_id>
    <nct_id>NCT01703585</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples</brief_title>
  <official_title>A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Institute for Cancer Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a feasibility study to look for genetic alterations in tissue and blood samples that&#xD;
      may be useful in determining what treatments may be useful in the patient's cancer care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As part of the study, patients will have archival tumor tissue collected, and have tumor&#xD;
      biopsies and blood samples taken. The samples will be tested for genetic alterations, and the&#xD;
      results will be discussed with the patient including potential treatments. If patients agree,&#xD;
      after they have received treatment for their cancer and their disease progresses, a second&#xD;
      biopsy procedure will be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2012</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%</measure>
    <time_frame>2 years</time_frame>
    <description>Sequenom or MiSeq/TSCAP and MiSeq/NGS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%</measure>
    <time_frame>2 years</time_frame>
    <description>Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Breast Cancer</condition>
  <condition>Gynecological Cancer</condition>
  <condition>Metastatic</condition>
  <condition>Eligible for Phase I or Phase II Study</condition>
  <condition>Melanoma Cancer</condition>
  <arm_group>
    <arm_group_label>metastatic breast cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>metastatic colorectal cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>metastatic gynecological cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>metastatic melanoma</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fresh tumor tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        metastatic breast, colorectal, gynecological cancer or melanoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Histological or cytological proof of either metastatic breast, colorectal,&#xD;
             gynecological or melanoma malignancy.&#xD;
&#xD;
          -  At least one biopsiable lesion deemed medically accessible and safe to biopsy.&#xD;
&#xD;
          -  Candidate for one or more phase I or II clinical trials at the time of study&#xD;
             enrollment or at a later time point.&#xD;
&#xD;
          -  Fulfills local institution's laboratory parameters for tumor biopsy.&#xD;
&#xD;
          -  Willingness and ability of patient to provide signed voluntary informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that could interfere with a patient's ability to provide informed&#xD;
             consent such as dementia or severe cognitive impairment.&#xD;
&#xD;
          -  Any contraindication to undergoing a biopsy procedure.&#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>Lillian Siu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bedard Philippe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>genomic analysis</keyword>
  <keyword>genome</keyword>
  <keyword>tumor</keyword>
  <keyword>tissue</keyword>
  <keyword>archival</keyword>
  <keyword>biopsy</keyword>
  <keyword>core needle</keyword>
  <keyword>fine needle</keyword>
  <keyword>DNA</keyword>
  <keyword>gene</keyword>
  <keyword>expression</keyword>
  <keyword>sequencing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Melanoma</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/NCT01703585
org study id: MATCH-001
nct id: NCT01703585
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is a feasibility study to look for genetic alterations in tissue and blood samples that
      may be useful in determining what treatments may be useful in the patient's cancer care.
As part of the study, patients will have archival tumor tissue collected, and have tumor
      biopsies and blood samples taken. The samples will be tested for genetic alterations, and the
      results will be discussed with the patient including potential treatments. If patients agree,
      after they have received treatment for their cancer and their disease progresses, a second
      biopsy procedure will be done.
observational model: Cohort
time perspective: Prospective
measure: Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.
time frame: 2 years
measure: The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%
time frame: 2 years
measure: The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%
time frame: 2 years
measure: Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%
time frame: 2 years
description: Sequenom or MiSeq/TSCAP and MiSeq/NGS
measure: Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%
time frame: 2 years
description: Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks
measure: Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%
time frame: 2 years
arm group label: metastatic breast cancer
arm group label: metastatic colorectal cancer
arm group label: metastatic gynecological cancer
arm group label: metastatic melanoma
Fresh tumor tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lillian Siu, MD
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
last name: Bedard Philippe, MD
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Melanoma