<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/NCT02260739</url>
  </required_header>
  <id_info>
    <org_study_id>2013-A00208-37</org_study_id>
    <secondary_id>2013/2031</secondary_id>
    <nct_id>NCT02260739</nct_id>
  </id_info>
  <brief_title>Sequential Analysis in Patients With an Hemopathy</brief_title>
  <acronym>S-HEMO</acronym>
  <official_title>Sequential Analysis in Patients With an Hemopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent advances in hematology clearly illustrate that the simple &quot;clonal&quot; nature of various&#xD;
      hematological malignancies may not really reflect the reality of malignant cells natural&#xD;
      expansion. This has been nicely illustrated in recent works in AML for example where&#xD;
      subclones coexists in the same patient at the same time, but could also differentially expand&#xD;
      over time because of effects of therapeutics intervention, but also by oncogenic spontaneous&#xD;
      events (1).&#xD;
&#xD;
      These observations have been done recently because of next generation sequencing that allows&#xD;
      to discriminate in the same tumor samples, different subclones and to analyse the clonal&#xD;
      architecture. Sequential analyses could help us to identify the first oncogenic event and to&#xD;
      correlate disease progression to the emergence of subclones.&#xD;
&#xD;
      For all these reasons it is of a major interest to precisely understand the architecture of&#xD;
      the clone in MPNs, especially to understand which is the initiating event and how from this&#xD;
      initial event the clone develops.&#xD;
&#xD;
      In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely&#xD;
      effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN,&#xD;
      but may favor the development of other malignant hemopathies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of new genetic alterations</measure>
    <time_frame>At baseline and then every 6 months up to 24 months</time_frame>
    <description>Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sequential analysis of the malignant clones</measure>
    <time_frame>At baseline and 12 months after inclusion</time_frame>
    <description>Sequential analysis of the malignant clones for each patient included in the trial using genetic markers</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">246</enrollment>
  <condition>Hemopathy</condition>
  <arm_group>
    <arm_group_label>chronic myelomonocytic leukemia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>essential thrombocytemia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>myelofibrosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood samples</intervention_name>
    <arm_group_label>chronic myelomonocytic leukemia</arm_group_label>
    <arm_group_label>essential thrombocytemia</arm_group_label>
    <arm_group_label>myelofibrosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a malignant hematological disease.&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Age and Sex : men and women aged 18 years or older&#xD;
&#xD;
          -  Patients affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients protected by law, in accordance with Articles L1121-L1121-5 to 8 of the Code of&#xD;
        Public Health.&#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>Vincent RIBRAG, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincent RIBRAG, MD</last_name>
    <phone>0142114507</phone>
    <phone_ext>+33</phone_ext>
    <email>vincent.ribrag@gustaveroussy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thibaud MOTREFF, MD</last_name>
    <phone>0142116643</phone>
    <phone_ext>+33</phone_ext>
    <email>thibaud.motreff@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent RIBRAG, MD</last_name>
      <phone>0142114507</phone>
      <phone_ext>+33</phone_ext>
      <email>vincent.ribrag@gustaveroussy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02260739
org study id: 2013-A00208-37
secondary id: 2013/2031
nct id: NCT02260739
lead sponsor: 
has dmc: No
Recent advances in hematology clearly illustrate that the simple "clonal" nature of various
      hematological malignancies may not really reflect the reality of malignant cells natural
      expansion. This has been nicely illustrated in recent works in AML for example where
      subclones coexists in the same patient at the same time, but could also differentially expand
      over time because of effects of therapeutics intervention, but also by oncogenic spontaneous
      events (1).

      These observations have been done recently because of next generation sequencing that allows
      to discriminate in the same tumor samples, different subclones and to analyse the clonal
      architecture. Sequential analyses could help us to identify the first oncogenic event and to
      correlate disease progression to the emergence of subclones.

      For all these reasons it is of a major interest to precisely understand the architecture of
      the clone in MPNs, especially to understand which is the initiating event and how from this
      initial event the clone develops.

      In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely
      effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN,
      but may favor the development of other malignant hemopathies.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Identification of new genetic alterations
time frame: At baseline and then every 6 months up to 24 months
description: Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples
measure: Sequential analysis of the malignant clones
time frame: At baseline and 12 months after inclusion
description: Sequential analysis of the malignant clones for each patient included in the trial using genetic markers
arm group label: chronic myelomonocytic leukemia
arm group type: Other
description: Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
arm group label: essential thrombocytemia
arm group type: Other
description: Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
arm group label: myelofibrosis
arm group type: Other
description: Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
intervention type: Other
intervention name: Blood samples
arm group label: chronic myelomonocytic leukemia
arm group label: essential thrombocytemia
arm group label: myelofibrosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent RIBRAG, MD
role: Study Chair
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
last name: Vincent RIBRAG, MD
phone: 0142114507
phone ext: +33
email: vincent.ribrag@gustaveroussy.fr
last name: Thibaud MOTREFF, MD
phone: 0142116643
phone ext: +33
email: thibaud.motreff@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor