<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/NCT02983539</url>
  </required_header>
  <id_info>
    <org_study_id>ACFrance</org_study_id>
    <nct_id>NCT02983539</nct_id>
  </id_info>
  <brief_title>Detection of Circulating Tumor Cells in Patients With Sarcomas</brief_title>
  <acronym>CTCS</acronym>
  <official_title>Detection of Circulating Tumor Cells in Patients With Metastatic Sarcomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AC Camargo Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AC Camargo Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and&#xD;
      10% in children. Even though it is a rare cancer, it contributes to a significant loss of&#xD;
      years of life in comparison with other types of cancer, due the fact that it affects children&#xD;
      and young people. The diagnosis and treatment are difficult, considering the diversity and&#xD;
      rarity of this disease. In addition, on average, more than 50% of patients with high-grade&#xD;
      sarcoma present tumor relapse and distant recurrence is considered the main cause of death.&#xD;
      The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be&#xD;
      an early marker of tumor invasion, because it is known that the CTCs circulate in the blood&#xD;
      for months or years before the development of metastases. The CTCs can be used to monitor the&#xD;
      response of the tumor to treatment, in order to match time, dose, and type of therapy.&#xD;
&#xD;
      Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma,&#xD;
      synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs.&#xD;
      The investigators also have an intention to identify genes of resistance to treatment in&#xD;
      these cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology: This is a prospective study, to be made by whole blood collection from 40&#xD;
      patients with different types of sarcomas (leiomyosarcoma, pleomorphic sarcoma, synovial&#xD;
      sarcoma and liposarcoma). The collections will be made in three different moments: before the&#xD;
      beginning of the treatment, during and at the end of this (8 mL). Blood samples will be&#xD;
      processed and filtered on ISET system for the isolation and quantification of CTCs. Later, it&#xD;
      will be performed immunocytochemistry (ICQ) single and/or double staining for protein&#xD;
      assessment. The following proteins will be assessed: CD45, MRP1, MRP2 and MRP7.&#xD;
&#xD;
      Expected Results: The investigators hope that this study can show if the CTCs can be used as&#xD;
      &quot;liquid biopsy&quot; in patients with leiomyosarcoma, synovium and pleomorphic sarcoma and&#xD;
      liposarcoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 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>progression free survival</measure>
    <time_frame>6 months</time_frame>
    <description>time to first progression until the second one</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Leiomyosarcoma</condition>
  <condition>Pleomorphic Liposarcoma</condition>
  <condition>Synovial Sarcoma</condition>
  <condition>Liposarcoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with 4 types of metastatic sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial&#xD;
        sarcoma and liposarcoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or more;&#xD;
&#xD;
          -  types of sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and&#xD;
             liposarcoma.&#xD;
&#xD;
          -  extension of the disease determined by physical examination and imaging;&#xD;
&#xD;
          -  measurable disease by RECIST criteria (Response Evaluation Criteria in Solid Tumors);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have undergone previous therapy in the last three weeks;&#xD;
&#xD;
          -  patients with a history of other cancer in the past two years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ludmilla Chinen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AC Camargo Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ludmilla Chinen, PhD</last_name>
    <phone>55 11 21895000</phone>
    <phone_ext>2776</phone_ext>
    <email>ludmilla.chinen@cipe.accamargo.org.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>ACCamargo Cancer Center</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01509900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludmilla Chinen, PhD</last_name>
      <phone>1121895000</phone>
      <phone_ext>2776</phone_ext>
      <email>ludmilla.chinen@accamargo.org.br</email>
    </contact>
    <investigator>
      <last_name>Ludmilla Chinen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Abdallah EA, Fanelli MF, Souza E Silva V, Machado Netto MC, Gasparini Junior JL, Araujo DV, Ocea LM, Buim ME, Tariki MS, Alves Vda S, Piana de Andrade V, Dettino AL, Abdon Lopes de Mello C, Chinen LT. MRP1 expression in CTCs confers resistance to irinotecan-based chemotherapy in metastatic colorectal cancer. Int J Cancer. 2016 Aug 15;139(4):890-8. doi: 10.1002/ijc.30082. Epub 2016 Apr 28.</citation>
    <PMID>26950035</PMID>
  </reference>
  <results_reference>
    <citation>Chinen LT, Mello CA, Abdallah EA, Ocea LM, Buim ME, Breve NM, Gasparini JL Junior, Fanelli MF, Paterlini-Brechot P. Isolation, detection, and immunomorphological characterization of circulating tumor cells (CTCs) from patients with different types of sarcoma using isolation by size of tumor cells: a window on sarcoma-cell invasion. Onco Targets Ther. 2014 Sep 16;7:1609-17. doi: 10.2147/OTT.S62349. eCollection 2014.</citation>
    <PMID>25258541</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>June 29, 2018</last_update_submitted>
  <last_update_submitted_qc>June 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AC Camargo Cancer Center</investigator_affiliation>
    <investigator_full_name>Ludmilla Thome Domingos Chinen, PhD</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>sarcomas</keyword>
  <keyword>immunocytochemistry</keyword>
  <keyword>circulating tumor cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
    <mesh_term>Leiomyosarcoma</mesh_term>
    <mesh_term>Liposarcoma</mesh_term>
    <mesh_term>Sarcoma, Synovial</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/NCT02983539
org study id: ACFrance
nct id: NCT02983539
lead sponsor: 
has dmc: Yes
The sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and
      10% in children. Even though it is a rare cancer, it contributes to a significant loss of
      years of life in comparison with other types of cancer, due the fact that it affects children
      and young people. The diagnosis and treatment are difficult, considering the diversity and
      rarity of this disease. In addition, on average, more than 50% of patients with high-grade
      sarcoma present tumor relapse and distant recurrence is considered the main cause of death.
      The presence of Circulating Tumor Cells (CTCs) in the blood of patients with sarcoma may be
      an early marker of tumor invasion, because it is known that the CTCs circulate in the blood
      for months or years before the development of metastases. The CTCs can be used to monitor the
      response of the tumor to treatment, in order to match time, dose, and type of therapy.

      Objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma,
      synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify CTCs.
      The investigators also have an intention to identify genes of resistance to treatment in
      these cells.
Methodology: This is a prospective study, to be made by whole blood collection from 40
      patients with different types of sarcomas (leiomyosarcoma, pleomorphic sarcoma, synovial
      sarcoma and liposarcoma). The collections will be made in three different moments: before the
      beginning of the treatment, during and at the end of this (8 mL). Blood samples will be
      processed and filtered on ISET system for the isolation and quantification of CTCs. Later, it
      will be performed immunocytochemistry (ICQ) single and/or double staining for protein
      assessment. The following proteins will be assessed: CD45, MRP1, MRP2 and MRP7.

      Expected Results: The investigators hope that this study can show if the CTCs can be used as
      "liquid biopsy" in patients with leiomyosarcoma, synovium and pleomorphic sarcoma and
      liposarcoma.
observational model: Cohort
time perspective: Prospective
measure: progression free survival
time frame: 6 months
description: time to first progression until the second one
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ludmilla Chinen, PhD
role: Principal Investigator
affiliation: AC Camargo Cancer Center
last name: Ludmilla Chinen, PhD
phone: 55 11 21895000
phone ext: 2776
email: ludmilla.chinen@cipe.accamargo.org.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
citation: Abdallah EA, Fanelli MF, Souza E Silva V, Machado Netto MC, Gasparini Junior JL, Araujo DV, Ocea LM, Buim ME, Tariki MS, Alves Vda S, Piana de Andrade V, Dettino AL, Abdon Lopes de Mello C, Chinen LT. MRP1 expression in CTCs confers resistance to irinotecan-based chemotherapy in metastatic colorectal cancer. Int J Cancer. 2016 Aug 15;139(4):890-8. doi: 10.1002/ijc.30082. Epub 2016 Apr 28.
PMID: 26950035
citation: Chinen LT, Mello CA, Abdallah EA, Ocea LM, Buim ME, Breve NM, Gasparini JL Junior, Fanelli MF, Paterlini-Brechot P. Isolation, detection, and immunomorphological characterization of circulating tumor cells (CTCs) from patients with different types of sarcoma using isolation by size of tumor cells: a window on sarcoma-cell invasion. Onco Targets Ther. 2014 Sep 16;7:1609-17. doi: 10.2147/OTT.S62349. eCollection 2014.
PMID: 25258541
responsible party type: Principal Investigator
investigator affiliation: AC Camargo Cancer Center
investigator full name: Ludmilla Thome Domingos Chinen, PhD
investigator title: Researcher
mesh term: Sarcoma
mesh term: Neoplastic Cells, Circulating
mesh term: Leiomyosarcoma
mesh term: Liposarcoma
mesh term: Sarcoma, Synovial
sharing ipd: No