<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/NCT03233763</url>
  </required_header>
  <id_info>
    <org_study_id>CCR4508</org_study_id>
    <nct_id>NCT03233763</nct_id>
  </id_info>
  <brief_title>Laboratory Studies Into the Pathology of Leukaemia</brief_title>
  <official_title>Laboratory Studies Into the Pathology of Leukaemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Marsden NHS Foundation Trust</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>
      Ongoing laboratory work into the pathology of Leukaemia:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will test AML samples sent to the diagnostic laboratory from participants&#xD;
      with newly diagnosed or relapsed/refractory AML. Samples will be sent from district general&#xD;
      hospitals and teaching hospitals.&#xD;
&#xD;
      Results will be returned to referring clinicians in the same way investigators currently&#xD;
      return results for samples sent for standard tests. The service will be advertised through&#xD;
      the Royal Marsden Website with visibility to both participants and HCPs). The investigators&#xD;
      will also inform all the clinicians involved in the AML working party (Dr Taussig is a member&#xD;
      of the AML working group).&#xD;
&#xD;
      In addition we are looking at diagnostic approaches to IDH 1 and 2 mutation identification.&#xD;
&#xD;
      An initial comparison of 50 samples by three analysis methods will be conducted.&#xD;
&#xD;
      IDH1 and IDH2 variant discovery will first be performed using an established standard in&#xD;
      house SOP (SOP: SMD103) for CE-SSCA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>Pathology of Leukaemia cells</measure>
    <time_frame>15 years</time_frame>
    <description>Pathology of Leukaemia cells</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Leukemia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone Marrow Aspirate</intervention_name>
    <description>Diagnostic Bone Marrow aspirate</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Bone Marrow and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This is an exploratory laboratory study using stored tissue where consent has already been&#xD;
        given.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18 &amp; Over Diagnosis of AML Generic Research consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Under 18 No generic research 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_official>
    <last_name>David Taussig</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leonora Conneely</last_name>
    <phone>0208 661 3018</phone>
    <email>leonora.conneely@rmh.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Haematology, the Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonora Conneely</last_name>
      <phone>0208 661 3018</phone>
      <email>HaematoOncRn@rmh.nhs.uk</email>
    </contact>
    <investigator>
      <last_name>David Taussig, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 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>Leukemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to patient tissue is via formal request to the Sponsor</ipd_description>
  </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/NCT03233763
org study id: CCR4508
nct id: NCT03233763
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ongoing laboratory work into the pathology of Leukaemia:
The investigators will test AML samples sent to the diagnostic laboratory from participants
      with newly diagnosed or relapsed/refractory AML. Samples will be sent from district general
      hospitals and teaching hospitals.

      Results will be returned to referring clinicians in the same way investigators currently
      return results for samples sent for standard tests. The service will be advertised through
      the Royal Marsden Website with visibility to both participants and HCPs). The investigators
      will also inform all the clinicians involved in the AML working party (Dr Taussig is a member
      of the AML working group).

      In addition we are looking at diagnostic approaches to IDH 1 and 2 mutation identification.

      An initial comparison of 50 samples by three analysis methods will be conducted.

      IDH1 and IDH2 variant discovery will first be performed using an established standard in
      house SOP (SOP: SMD103) for CE-SSCA
observational model: Cohort
time perspective: Prospective
measure: Pathology of Leukaemia cells
time frame: 15 years
description: Pathology of Leukaemia cells
intervention type: Procedure
intervention name: Bone Marrow Aspirate
description: Diagnostic Bone Marrow aspirate
Bone Marrow and blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Taussig
role: Principal Investigator
affiliation: Royal Marsden NHS Foundation Trust
last name: Leonora Conneely
phone: 0208 661 3018
email: leonora.conneely@rmh.nhs.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Leukemia
sharing ipd: Yes
ipd description: Access to patient tissue is via formal request to the Sponsor