<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/NCT03800121</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A01393-52</org_study_id>
    <nct_id>NCT03800121</nct_id>
  </id_info>
  <brief_title>Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)</brief_title>
  <acronym>EXOSARC</acronym>
  <official_title>Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Georges Francois Leclerc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Georges Francois Leclerc</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>
      Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative&#xD;
      factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is&#xD;
      very complex given the histological heterogeneity of this entity. It is therefore essential&#xD;
      that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to&#xD;
      adapt the therapeutic strategy as well as possible.&#xD;
&#xD;
      It has recently been discovered that sarcomas secrete many exosomes that appear to play an&#xD;
      important role in tumorogenesis, growth, tumor progression and the onset of metastases. They&#xD;
      contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics&#xD;
      of the tumor. It has been shown that the amount of exosomes can be correlated with the grade&#xD;
      of malignancy of the tumor. Present in the blood, exosomes offer the possibility of&#xD;
      non-invasively analyzing the molecular information of the cancer cell. As a result, the study&#xD;
      of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate&#xD;
      cancer pathogenesis, progression, and treatment efficacy.&#xD;
&#xD;
      The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be&#xD;
      used to monitor their disease and be used as a predictor of the risk of recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this pilot study is to quantify exosomes and analyze their protein and&#xD;
      RNA content in patients with sarcoma with disease:&#xD;
&#xD;
        -  localized before and after treatment with surgery,&#xD;
&#xD;
        -  for which neoadjuvant chemotherapy is being considered&#xD;
&#xD;
        -  metastatic or locally advanced cancer before and after treatment with first-line&#xD;
           chemotherapywhich may include neoadjuvant therapy&#xD;
&#xD;
      The secondary objectives are:&#xD;
&#xD;
        1. Determine whether the initial exosome concentration and the protein and RNA profile they&#xD;
           contain vary with the localized or metastatic stage of the disease.&#xD;
&#xD;
        2. Determine if the exosome concentration as well as the protein and RNA profile they&#xD;
           contain varies after treatment.&#xD;
&#xD;
        3. Determine if the initial exosome concentration (at T0) is associated with a response to&#xD;
           treatment.&#xD;
&#xD;
        4. Determine whether the change in exosome concentration before and after treatment is&#xD;
           associated with a response to treatment.&#xD;
&#xD;
        5. Identify a protein marker or RNA associated with a treatment response (marker present at&#xD;
           T0 or occurring during follow-up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">November 19, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 19, 2022</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>concentration of exosomes in blood</measure>
    <time_frame>up to 6 months after inclusion</time_frame>
    <description>blood samples</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>Localized sarcoma with neoadjuvant chemotherapy</arm_group_label>
    <description>In total, several blood tests specific to the EXOSARC study will be necessary:&#xD;
A first blood test of 7 mL during the initial assessment (inclusion)&#xD;
Then four blood samples of 32mL distributed over 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metastatic or locally advanced sarcoma</arm_group_label>
    <description>In total, several blood tests specific to the EXOSARC study will be necessary :&#xD;
A first blood of 7 mL during the initial assessment (inclusion)&#xD;
Then three blood samples of 32 mL distribuated over 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <description>Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml)&#xD;
Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml)</description>
    <arm_group_label>Localized sarcoma with neoadjuvant chemotherapy</arm_group_label>
    <arm_group_label>Metastatic or locally advanced sarcoma</arm_group_label>
    <other_name>Localized sarcoma</other_name>
    <other_name>Metastatic sarcoma</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with soft tissue sarcoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women newly diagnosed with localized, metastatic or locally advanced soft&#xD;
             tissue sarcoma&#xD;
&#xD;
          2. Previous treatment of the disease with chemotherapy, radiotherapy or surgery is&#xD;
             allowed if it has been completed for more than 12 months at the time of inclusion.&#xD;
&#xD;
          3. For metastatic or locally advanced (inoperable) sarcoma, patients for whom first-line&#xD;
             metastatic chemotherapy is indicated.&#xD;
&#xD;
          4. Age ≥18 years&#xD;
&#xD;
          5. Affiliation to a social security scheme&#xD;
&#xD;
          6. Patients who signed informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet at least one of the following criteria will not be eligible:&#xD;
&#xD;
          1. Patient with another synchronous tumor,&#xD;
&#xD;
          2. Patient with sarcoma in irradiated territory&#xD;
&#xD;
          3. Patient with a history of cancer other than sarcoma in the 5 years preceding the&#xD;
             diagnosis of sarcoma&#xD;
&#xD;
          4. Patient unable to undergo medical follow-up for geographical, social or psychological&#xD;
             reasons,&#xD;
&#xD;
          5. Person benefiting from a protection system for adults (including guardianship and&#xD;
             trusteeship),&#xD;
&#xD;
          6. Serology HIV and / or HBV and / or HCV positive.&#xD;
&#xD;
          7. Pregnant or lactating woman.&#xD;
&#xD;
          8. Patients unable to understand, read and / or sign informed consent.&#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_contact>
    <last_name>Alice HERVIEU</last_name>
    <phone>03 80 73 75 00</phone>
    <email>ahervieu@cgfl.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emilie REDERSTORFF</last_name>
    <phone>03 80 73 75 00</phone>
    <email>erederstorff@cgfl.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Loic CHAIGNEAU</last_name>
    </contact>
    <contact_backup>
      <email>echaigneau@chu-besancon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Elsa KALBACHER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guillaume MEYNARD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Georges François Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice HERVIEU</last_name>
      <phone>03 80 73 75 00</phone>
      <email>ahervieu@cgfl.fr</email>
    </contact>
    <investigator>
      <last_name>Sylvain CAUSERET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle DESMOULINS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas ISAMBERT, PU-PH</last_name>
      <phone>05 49 44 45 38</phone>
      <email>nicolas.isambert@chu-poitiers.fr</email>
    </contact>
    <investigator>
      <last_name>Sheik EMAMBUX</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Camille EVRARD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exosomes</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/NCT03800121
org study id: 2018-A01393-52
nct id: NCT03800121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative
      factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is
      very complex given the histological heterogeneity of this entity. It is therefore essential
      that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to
      adapt the therapeutic strategy as well as possible.

      It has recently been discovered that sarcomas secrete many exosomes that appear to play an
      important role in tumorogenesis, growth, tumor progression and the onset of metastases. They
      contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics
      of the tumor. It has been shown that the amount of exosomes can be correlated with the grade
      of malignancy of the tumor. Present in the blood, exosomes offer the possibility of
      non-invasively analyzing the molecular information of the cancer cell. As a result, the study
      of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate
      cancer pathogenesis, progression, and treatment efficacy.

      The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be
      used to monitor their disease and be used as a predictor of the risk of recurrence.
The main objective of this pilot study is to quantify exosomes and analyze their protein and
      RNA content in patients with sarcoma with disease:

        -  localized before and after treatment with surgery,

        -  for which neoadjuvant chemotherapy is being considered

        -  metastatic or locally advanced cancer before and after treatment with first-line
           chemotherapywhich may include neoadjuvant therapy

      The secondary objectives are:

        1. Determine whether the initial exosome concentration and the protein and RNA profile they
           contain vary with the localized or metastatic stage of the disease.

        2. Determine if the exosome concentration as well as the protein and RNA profile they
           contain varies after treatment.

        3. Determine if the initial exosome concentration (at T0) is associated with a response to
           treatment.

        4. Determine whether the change in exosome concentration before and after treatment is
           associated with a response to treatment.

        5. Identify a protein marker or RNA associated with a treatment response (marker present at
           T0 or occurring during follow-up).
observational model: Cohort
time perspective: Prospective
measure: concentration of exosomes in blood
time frame: up to 6 months after inclusion
description: blood samples
arm group label: Localized sarcoma with neoadjuvant chemotherapy
description: In total, several blood tests specific to the EXOSARC study will be necessary:
A first blood test of 7 mL during the initial assessment (inclusion)
Then four blood samples of 32mL distributed over 6 months
arm group label: Metastatic or locally advanced sarcoma
description: In total, several blood tests specific to the EXOSARC study will be necessary :
A first blood of 7 mL during the initial assessment (inclusion)
Then three blood samples of 32 mL distribuated over 3 months
intervention type: Biological
intervention name: Blood samples
description: Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml)
Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml)
arm group label: Localized sarcoma with neoadjuvant chemotherapy
arm group label: Metastatic or locally advanced sarcoma
other name: Localized sarcoma
other name: Metastatic sarcoma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alice HERVIEU
phone: 03 80 73 75 00
email: ahervieu@cgfl.fr
last name: Emilie REDERSTORFF
phone: 03 80 73 75 00
email: erederstorff@cgfl.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Sarcoma