<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/NCT03294980</url>
  </required_header>
  <id_info>
    <org_study_id>OFICE</org_study_id>
    <nct_id>NCT03294980</nct_id>
  </id_info>
  <brief_title>Chronic Lymphoid Leukaemia Observatory in Finistere Area, France</brief_title>
  <acronym>OFICE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <brief_summary>
    <textblock>
      Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL&#xD;
      patients' population from the Finistere area and evaluates the association between different&#xD;
      patient characteristics, prognosis and treatment patterns.&#xD;
&#xD;
      Detailed Description: OFICE is a single center, prospective, observational registry of CLL&#xD;
      patients designed to provide a general description of the CLL patients' population from the&#xD;
      Finistere area, France. The registry will also provide information on the association of&#xD;
      cytogenetic and immunophenotypic characteristics with disease progression, as well as&#xD;
      treatment patterns and healthcare resource utilization. These data will be accessible and&#xD;
      beneficial for researchers and physicians and will help guide clinical practice and future&#xD;
      clinical or fundamental studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">November 2025</completion_date>
  <primary_completion_date type="Anticipated">November 2025</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>Prevalence</measure>
    <time_frame>Year 0 (Y)</time_frame>
    <description>Clinical data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence</measure>
    <time_frame>Year 0</time_frame>
    <description>Clinical and biological data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of baseline clinical-biological</measure>
    <time_frame>Year 0, Year 1, Year 2, Year 3</time_frame>
    <description>Clinical data, complete blood count, Matutes score and parameters, cytogenetic, IgVH mutations, CD38 (%), medical treatment will be collected</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Chronic Lymphoid Leukaemia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      cell pellet More than 95% CD5+CD19+ lymphocytes&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with Chronic Lymphoid Leukaemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of at least 18 years&#xD;
&#xD;
          -  Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Willing and able to provide blood sample at time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of other B-cell malignancies&#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>Yves Reanudineau</last_name>
    <role>Study Director</role>
    <affiliation>CHRU de Brest</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yves Renaudineau</last_name>
    <email>yves.renaudineau@chu-brest.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yves Renaudineau</last_name>
      <email>Yves.renaudineau@chu-brest.fr</email>
    </contact>
    <contact_backup>
      <last_name>Adrian Tempescul</last_name>
      <email>adrian.tempescul@chu-brest.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 26, 2016</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic lymphocytic leukemia</keyword>
  <keyword>Observational study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</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/NCT03294980
org study id: OFICE
nct id: NCT03294980
lead sponsor: 
Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL
      patients' population from the Finistere area and evaluates the association between different
      patient characteristics, prognosis and treatment patterns.

      Detailed Description: OFICE is a single center, prospective, observational registry of CLL
      patients designed to provide a general description of the CLL patients' population from the
      Finistere area, France. The registry will also provide information on the association of
      cytogenetic and immunophenotypic characteristics with disease progression, as well as
      treatment patterns and healthcare resource utilization. These data will be accessible and
      beneficial for researchers and physicians and will help guide clinical practice and future
      clinical or fundamental studies.
observational model: Cohort
time perspective: Prospective
measure: Prevalence
time frame: Year 0 (Y)
description: Clinical data
measure: Incidence
time frame: Year 0
description: Clinical and biological data
measure: Description of baseline clinical-biological
time frame: Year 0, Year 1, Year 2, Year 3
description: Clinical data, complete blood count, Matutes score and parameters, cytogenetic, IgVH mutations, CD38 (%), medical treatment will be collected
cell pellet More than 95% CD5+CD19+ lymphocytes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yves Reanudineau
role: Study Director
affiliation: CHRU de Brest
last name: Yves Renaudineau
email: yves.renaudineau@chu-brest.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell