<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/NCT01720758</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-0124-11-CTIL</org_study_id>
    <nct_id>NCT01720758</nct_id>
  </id_info>
  <brief_title>Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease</brief_title>
  <acronym>B-RAF V600E</acronym>
  <official_title>Assessment of the V600E Mutation in the B-RAF Gene in Chronic Lymphoproliferative Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The presence of a specific mutation in the gene known as B-RAF has been found in patients who&#xD;
      have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be&#xD;
      ascertained in peripheral blood samples of patients who have this disease and in a group of&#xD;
      patients who have a similar chronic lymphoproliferative conditions such as splenic marginal&#xD;
      lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis&#xD;
      of Hairy Cell Leukemia and determine whether patients are in remission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>detection of the B-RAF V600E mutation</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Hairy Cell Leukemia</condition>
  <condition>Splenic Marginal Zone Lymphoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      perpheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are followed up in the Haematology Department in the Emek Medical Center for&#xD;
        Hairy Cell Leukemia or chronic lymphoproliferative disease such as Splenic Marginal Zone&#xD;
        Lymphoma. Patients who are examined and suspected to have Hairy Cell Leukemia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients over the age of 18 years -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients less than 18 years in age or mentally defectives.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, B-Cell, Marginal Zone</mesh_term>
    <mesh_term>Leukemia, Hairy Cell</mesh_term>
    <mesh_term>Lymphoproliferative Disorders</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/NCT01720758
org study id: EMC-0124-11-CTIL
nct id: NCT01720758
lead sponsor: 
has dmc: No
The presence of a specific mutation in the gene known as B-RAF has been found in patients who
      have Hairy Cell Leukemia. In this study this specific mutation known as V600E will be
      ascertained in peripheral blood samples of patients who have this disease and in a group of
      patients who have a similar chronic lymphoproliferative conditions such as splenic marginal
      lymphoma. The finding of this specific mutation will help to verify or exclude the diagnosis
      of Hairy Cell Leukemia and determine whether patients are in remission.
observational model: Other
time perspective: Prospective
measure: detection of the B-RAF V600E mutation
time frame: 2 weeks
perpheral blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lymphoma, B-Cell, Marginal Zone
mesh term: Leukemia, Hairy Cell
mesh term: Lymphoproliferative Disorders