<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/NCT03818412</url>
  </required_header>
  <id_info>
    <org_study_id>DNA-TSAR</org_study_id>
    <nct_id>NCT03818412</nct_id>
  </id_info>
  <brief_title>Circulating Tumor DNA in Soft Tissue Sarcoma</brief_title>
  <official_title>Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</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 research study will collect blood and tumor tissue samples from patients with soft&#xD;
      tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA). When tumor cells are&#xD;
      damaged or die, DNA from the tumor cells are released into the blood stream as the cells&#xD;
      break down. This is called circulating tumor DNA. Circulating tumor DNA is an important&#xD;
      biomarker that may be used in cancer detection, prediction of treatment response, and disease&#xD;
      monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Researchers are continually looking for ways to understand the biology of cancer such as&#xD;
      sarcoma, and ways to improve cancer care and patient outcome.&#xD;
&#xD;
      Research has shown that changes in some genes and/or proteins, called biomarkers, may be&#xD;
      important indicators for certain cancers and response to treatments. Genes are molecules made&#xD;
      up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for&#xD;
      the development and functioning of the cells in the body and are passed down from parent to&#xD;
      child. RNA is involved with producing proteins in the body. Further research is needed to&#xD;
      better understand the changes found in cancer cells and what this means for certain&#xD;
      treatments.&#xD;
&#xD;
      Circulating tumor DNA is an important biomarker that may be used in cancer detection,&#xD;
      prediction of treatment response and disease monitoring. When tumor cells are damaged or die,&#xD;
      DNA from the tumor cells are released into the blood stream as the cells break down. This is&#xD;
      called circulating tumor DNA. Researchers are looking for better ways to detect circulating&#xD;
      tumor DNA so that it can be studied.&#xD;
&#xD;
      The purpose of this study is to determine how feasible it is to detect circulating tumor DNA&#xD;
      in blood samples of soft tissue sarcoma patients and whether there is a connection between&#xD;
      circulating tumor DNA and the likelihood of patients' disease coming back after they receive&#xD;
      treatment. To do this, blood and tumor tissue samples will be collected from participants and&#xD;
      will undergo DNA testing (reading the contents of their DNA, called sequencing). The results&#xD;
      of the DNA testing in the blood samples will be compared with the results from DNA testing&#xD;
      that will also be done on tumor tissue. The results will also be compared with participant's&#xD;
      response to their treatment, recurrence, and/or long term survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">January 17, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 17, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>Soft Tissue Sarcoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A sample of archival tumor tissue will be collected.&#xD;
Blood samples (about 20-30 mL or 1-2 tablespoons each sample) will be taken:&#xD;
Prior to planned radiation treatment&#xD;
2-4 weeks after cancer surgery&#xD;
Every 12 weeks after surgery for up to 2 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Archival tumor tissue collection and blood draws</intervention_name>
    <description>Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.</description>
    <arm_group_label>Soft Tissue Sarcoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed high-risk extremity or retroperitoneal&#xD;
             liposarcoma, leiomyosarcoma and undifferentiated pleomorphic sarcoma.&#xD;
&#xD;
          -  Patients must have archival tissue from the diagnostic biopsy available.&#xD;
&#xD;
          -  Deemed appropriate for preoperative or postoperative radiotherapy and curative surgery&#xD;
             following patient assessment by radiation oncologist and surgical oncologist.&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Eastern Cooperative Group (ECOG) performance status ≤ 2&#xD;
&#xD;
          -  Ability to understand and willing to sign a written informed consent document and&#xD;
             comply with study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with benign histology&#xD;
&#xD;
          -  Patients with prior malignancy within previous 5 years or concurrent malignancy other&#xD;
             than adequately treated basal cell carcinoma of skin or carcinoma in-situ of cervix.&#xD;
&#xD;
          -  Patients with planned neo-adjuvant chemotherapy.&#xD;
&#xD;
          -  Patients with regional nodal disease or unequivocal metastases&#xD;
&#xD;
          -  Uncontrolled inter-current illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#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>Albiruni Razak, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princess Margaret Cancer Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Albiruni Razak, M.D.</last_name>
    <phone>416-946-2000</phone>
    <email>albiruni.razak@uhn.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pernille Pedersen, R.N.</last_name>
    <phone>416-946-4501</phone>
    <phone_ext>2502</phone_ext>
    <email>pernille.pederson@uhn.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Albiruni Razak, M.D.</last_name>
      <phone>416-946-2000</phone>
      <email>albiruni.razak@uhn.ca</email>
    </contact>
    <contact_backup>
      <last_name>Limore Arones, R.N.</last_name>
      <phone>416-946-4501</phone>
      <phone_ext>2504</phone_ext>
      <email>limore.arones@uhn.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Albiruni Razak, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 8, 2023</last_update_submitted>
  <last_update_submitted_qc>January 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Circulating tumor DNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</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/NCT03818412
org study id: DNA-TSAR
nct id: NCT03818412
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study will collect blood and tumor tissue samples from patients with soft
      tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA). When tumor cells are
      damaged or die, DNA from the tumor cells are released into the blood stream as the cells
      break down. This is called circulating tumor DNA. Circulating tumor DNA is an important
      biomarker that may be used in cancer detection, prediction of treatment response, and disease
      monitoring.
Researchers are continually looking for ways to understand the biology of cancer such as
      sarcoma, and ways to improve cancer care and patient outcome.

      Research has shown that changes in some genes and/or proteins, called biomarkers, may be
      important indicators for certain cancers and response to treatments. Genes are molecules made
      up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for
      the development and functioning of the cells in the body and are passed down from parent to
      child. RNA is involved with producing proteins in the body. Further research is needed to
      better understand the changes found in cancer cells and what this means for certain
      treatments.

      Circulating tumor DNA is an important biomarker that may be used in cancer detection,
      prediction of treatment response and disease monitoring. When tumor cells are damaged or die,
      DNA from the tumor cells are released into the blood stream as the cells break down. This is
      called circulating tumor DNA. Researchers are looking for better ways to detect circulating
      tumor DNA so that it can be studied.

      The purpose of this study is to determine how feasible it is to detect circulating tumor DNA
      in blood samples of soft tissue sarcoma patients and whether there is a connection between
      circulating tumor DNA and the likelihood of patients' disease coming back after they receive
      treatment. To do this, blood and tumor tissue samples will be collected from participants and
      will undergo DNA testing (reading the contents of their DNA, called sequencing). The results
      of the DNA testing in the blood samples will be compared with the results from DNA testing
      that will also be done on tumor tissue. The results will also be compared with participant's
      response to their treatment, recurrence, and/or long term survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification
time frame: 5 years
measure: Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence
time frame: 5 years
arm group label: Soft Tissue Sarcoma
arm group type: Experimental
description: A sample of archival tumor tissue will be collected.
Blood samples (about 20-30 mL or 1-2 tablespoons each sample) will be taken:
Prior to planned radiation treatment
2-4 weeks after cancer surgery
Every 12 weeks after surgery for up to 2 years
intervention type: Procedure
intervention name: Archival tumor tissue collection and blood draws
description: Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.
arm group label: Soft Tissue Sarcoma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Albiruni Razak, M.D.
role: Principal Investigator
affiliation: Princess Margaret Cancer Centre
last name: Albiruni Razak, M.D.
phone: 416-946-2000
email: albiruni.razak@uhn.ca
last name: Pernille Pedersen, R.N.
phone: 416-946-4501
phone ext: 2502
email: pernille.pederson@uhn.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Sarcoma