<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/NCT04477564</url>
  </required_header>
  <id_info>
    <org_study_id>NIMAO/2020-01/SB-01</org_study_id>
    <nct_id>NCT04477564</nct_id>
  </id_info>
  <brief_title>Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism</brief_title>
  <acronym>CHIPS</acronym>
  <official_title>Screening of Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</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>
      The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate&#xD;
      potential (CHIP) in patients with a history of venous thromboembolism.&#xD;
&#xD;
      The study investigators make the assumption that these patients present mutations involved in&#xD;
      CHIP occurrence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DNMT3A mutations screening</measure>
    <time_frame>For sequencing analysis: 2 months</time_frame>
    <description>Next generation sequencing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening</measure>
    <time_frame>For sequencing analysis: 2 months</time_frame>
    <description>Next generation sequencing</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Venous Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Unprovoked proximal deep vein thrombosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Provoked distal deep vein thrombosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>age-matched control group with no history of vein thrombosis</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      gDNA from leucocytes from a biobank (registration number DC-2008-290 and authorization number&#xD;
      AC-2008-107)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women over 50 years old who have consulted at the Hematology laboratory of the&#xD;
        Nîmes University Hospital for the occurrence or history of venous thromboembolism&#xD;
        (Distal/proximal; Provoked/unprovoked) and who has accepted that their DNA was kept and&#xD;
        used in the context of research on venous thromboembolism&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women over 50 years old who have consulted at the Hematology laboratory of the&#xD;
             Nîmes University Hospital for the occurrence or history of venous thromboembolism&#xD;
&#xD;
          -  Patient who has accepted that their DNA was kept and used in the context of research&#xD;
             on venous thromboembolism (biobank (registration number DC-2008-290 and authorization&#xD;
             number AC-2008-107))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 50 years old&#xD;
&#xD;
          -  Patient who has refused that their DNA was kept and used in the context of research on&#xD;
             venous thromboembolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Nimes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clonal Hematopoiesis of indeterminate potential</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</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/NCT04477564
org study id: NIMAO/2020-01/SB-01
nct id: NCT04477564
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate
      potential (CHIP) in patients with a history of venous thromboembolism.

      The study investigators make the assumption that these patients present mutations involved in
      CHIP occurrence.
observational model: Case-Crossover
time perspective: Retrospective
measure: DNMT3A mutations screening
time frame: For sequencing analysis: 2 months
description: Next generation sequencing
measure: TET2, ASXL1, TP53, JAK2, SF3B1, SRSF2, GNB1, CBL, BCOR, SH2B3, PPM1D mutations screening
time frame: For sequencing analysis: 2 months
description: Next generation sequencing
arm group label: Unprovoked proximal deep vein thrombosis
arm group label: Provoked distal deep vein thrombosis
arm group label: age-matched control group with no history of vein thrombosis
gDNA from leucocytes from a biobank (registration number DC-2008-290 and authorization number
      AC-2008-107)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
sharing ipd: No