xml: <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/NCT05968417</url>
    </required_header>
    <id_info>
      <org_study_id>CCR5106</org_study_id>
      <nct_id>NCT05968417</nct_id>
    </id_info>
    <brief_title>Myeloma Novel Drug Discovery Ver 1.2</brief_title>
    <acronym>DISCO</acronym>
    <official_title>Investigation of the Activity of Novel Compounds for the Treatment of Myeloma and Mechanisms of Drug Resistance to Current Therapies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Cancer Research, United Kingdom</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Royal Marsden NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institute of Cancer Research, United Kingdom</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Myeloma is a bone marrow cancer with over 5000 patients diagnosed in the UK each year.&#xD;
        Researchers are committed to improving understanding of myeloma and developing more effective&#xD;
        treatments with fewer side effects in order to improve patient outcomes. In order to do this,&#xD;
        researchers are collecting samples of blood and bone marrow to test the activity of potential&#xD;
        new treatments in the laboratory and to understand what may be the cause of some treatments&#xD;
        not working.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 22, 2020</start_date>
    <completion_date type="Anticipated">February 28, 2035</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2033</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>Cell viability</measure>
      <time_frame>12 months</time_frame>
      <description>Myeloma cell viability when incubated with standard of care and novel compounds.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Participants with a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder</arm_group_label>
      <description>Participants who are undergoing peripheral blood or bone marrow aspirate sampling for diagnostic, staging or follow-up purposes, before, whilst or after receiving anti-myeloma treatment will be approached to collect additional samples for research.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational study - sample collection only.</intervention_name>
      <description>No intervention - blood and/or bone marrow sample collection only</description>
      <arm_group_label>Participants with a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants who have a diagnosis, or suspected diagnosis, of myeloma or related plasma&#xD;
          cell disorder&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants who have a diagnosis, or suspected diagnosis, of myeloma or related&#xD;
               plasma cell disorder&#xD;
  &#xD;
            2. Participants who are undergoing a peripheral blood or bone marrow aspirate sampling&#xD;
               for diagnostic, staging or follow-up purposes, before, whilst or after receiving&#xD;
               anti-myeloma treatment&#xD;
  &#xD;
            3. Participants aged 18 years of age or above&#xD;
  &#xD;
            4. Participants willing to consent to an additional sample being taken at the time of&#xD;
               their peripheral blood or bone marrow aspirate sampling&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants unable to provide consent&#xD;
  &#xD;
            2. Participants with known active infectious diseases (e.g. HIV, Hepatitis B/C, COVID)&#xD;
               that pose a risk to the use of the sample in the laboratory&#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_contact>
      <last_name>Disco Team</last_name>
      <phone>020 3186 5275</phone>
      <email>Disco.iras263630@nhs.net</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Royal Marsden NHS Foundation Trust</name>
        <address>
          <city>London Borough of Sutton</city>
          <zip>SM25PT</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chloe Burrows</last_name>
        <email>chloe.burrows@rmh.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Charlotte Pawlyn</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968417
  org study id: CCR5106
  nct id: NCT05968417
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Myeloma is a bone marrow cancer with over 5000 patients diagnosed in the UK each year.
        Researchers are committed to improving understanding of myeloma and developing more effective
        treatments with fewer side effects in order to improve patient outcomes. In order to do this,
        researchers are collecting samples of blood and bone marrow to test the activity of potential
        new treatments in the laboratory and to understand what may be the cause of some treatments
        not working.
  observational model: Cohort
  time perspective: Prospective
  measure: Cell viability
  time frame: 12 months
  description: Myeloma cell viability when incubated with standard of care and novel compounds.
  arm group label: Participants with a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder
  description: Participants who are undergoing peripheral blood or bone marrow aspirate sampling for diagnostic, staging or follow-up purposes, before, whilst or after receiving anti-myeloma treatment will be approached to collect additional samples for research.
  intervention type: Other
  intervention name: Observational study - sample collection only.
  description: No intervention - blood and/or bone marrow sample collection only
  arm group label: Participants with a diagnosis, or suspected diagnosis, of myeloma or related plasma cell disorder
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Disco Team
  phone: 020 3186 5275
  email: Disco.iras263630@nhs.net
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell