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/NCT06007989</url>
    </required_header>
    <id_info>
      <org_study_id>CFTsp212</org_study_id>
      <nct_id>NCT06007989</nct_id>
    </id_info>
    <brief_title>Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)</brief_title>
    <acronym>CHIME</acronym>
    <official_title>Assessing the Relationship Between Hypoxia and the Immune Environment in Myeloma Patients (CHIME)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Christie NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Christie 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>
        The study is looking at how myeloma is related to low oxygen levels (hypoxia) in the bone&#xD;
        marrow. This is to understand the disease better. It might also guide treatment in the&#xD;
        future.&#xD;
  &#xD;
        For the study, we will run tests on a portion of the samples taken during a bone marrow&#xD;
        biopsy. A bone marrow biopsy is taken as part of the diagnosis or follow up of myeloma. The&#xD;
        tests in our study will look closely at the make-up of immune cells in the bone marrow,&#xD;
        highlight areas of low oxygen, and look at genetic changes in cells from low-oxygen areas. We&#xD;
        will ask patients to take a capsule the day before their bone marrow biopsy containing&#xD;
        pimonidazole hydrochloride, a substance which will show up areas of low oxygen on tests.&#xD;
  &#xD;
        Overall we want to know:&#xD;
  &#xD;
          1. If myeloma cells 'live' in areas of low oxygen in the bone marrow&#xD;
  &#xD;
          2. What are the immune and bone marrow cells which are neighbours of myeloma cells?&#xD;
  &#xD;
          3. Are there genetic changes in low oxygen myeloma cells&#xD;
  &#xD;
             For the pilot study, we want to know:&#xD;
  &#xD;
          4. Can we use new techniques to study questions 1-3? The techniques we want to use are&#xD;
             pimonidazole with multiplex immunohistochemistry and single cell RNA sequencing.&#xD;
  &#xD;
        The information we get from the tests will help us get a better understanding of how myeloma&#xD;
        works. Future studies may also use these results to develop new kinds of drugs for myeloma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Qualitative assessment of the utility of a set of investigational tools for investigating the bone marrow microenvironment in myeloma patients</measure>
      <time_frame>Assessment is at the time of diagnosis.</time_frame>
      <description>Specifically we aim to determine the feasibility of using pimonidazole as a marker of hypoxia in conjunction with: A) Multiplex immunohistochemistry to characterise the spatial organization of cellular inflammatory elements and myeloma cells in the bone marrow, B)Single cell RNA sequencing to characterise the expression profile of myeloma cells in hypoxic areas of marrow</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Myeloma</condition>
    <arm_group>
      <arm_group_label>Basic science study, no intervention.</arm_group_label>
      <description>Basic science study, no intervention.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patient with newly diagnosed or previously treated myeloma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Male or female patients referred to The Christie NHS Foundation Trust from another&#xD;
               hospital with proven multiple myeloma which may be either treatment naïve or&#xD;
               previously treated.&#xD;
  &#xD;
               2. Aged 18 or over 3. World Health Organisation (WHO) performance status 0 to 2 with&#xD;
               no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks 4.&#xD;
               Provision of written informed consent 5. Willing to undergo a bone marrow biopsy 6.&#xD;
               Willing to take pimonidazole hydrochloride&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Involvement in the planning and/or conduct of the study (applies to staff at the study&#xD;
               site)&#xD;
  &#xD;
            2. Evidence of any significant clinical disorder or laboratory finding that made it&#xD;
               undesirable for the patient to participate in the study&#xD;
  &#xD;
            3. Judgment by the investigator that the patient should not participate in the study if&#xD;
               the patient is unlikely to comply with study procedures, restrictions, and&#xD;
               requirements&#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>Emma Searle, MBChB, MA, MRCP, FRCPath, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manchester, The Christie NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Adam Jones, MBBS, MSc, MRCP</last_name>
      <phone>+44 161 276 1234</phone>
      <email>adam.jones35@nhs.net</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Christie NHS Foundation Trust</name>
        <address>
          <city>Manchester</city>
          <state>Greater Manchester</state>
          <zip>M20 4BX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Clare Griffin, MA, PhD</last_name>
        <phone>+44 161 446 3000</phone>
        <email>clare.griffin1@nhs.net</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>multiplex</keyword>
    <keyword>immunohistochemistry</keyword>
    <keyword>hypoxia</keyword>
    <keyword>single-cell RNA sequencing</keyword>
    <keyword>pimonidazole</keyword>
    <keyword>myeloma</keyword>
    <keyword>microenvironment</keyword>
    <keyword>metabolomics</keyword>
    <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>
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual patient level data is unlikely to be useful to other groups in this small pilot study.</ipd_description>
    </patient_data>
    <!-- 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/NCT06007989
  org study id: CFTsp212
  nct id: NCT06007989
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is looking at how myeloma is related to low oxygen levels (hypoxia) in the bone
        marrow. This is to understand the disease better. It might also guide treatment in the
        future.
  
        For the study, we will run tests on a portion of the samples taken during a bone marrow
        biopsy. A bone marrow biopsy is taken as part of the diagnosis or follow up of myeloma. The
        tests in our study will look closely at the make-up of immune cells in the bone marrow,
        highlight areas of low oxygen, and look at genetic changes in cells from low-oxygen areas. We
        will ask patients to take a capsule the day before their bone marrow biopsy containing
        pimonidazole hydrochloride, a substance which will show up areas of low oxygen on tests.
  
        Overall we want to know:
  
          1. If myeloma cells 'live' in areas of low oxygen in the bone marrow
  
          2. What are the immune and bone marrow cells which are neighbours of myeloma cells?
  
          3. Are there genetic changes in low oxygen myeloma cells
  
             For the pilot study, we want to know:
  
          4. Can we use new techniques to study questions 1-3? The techniques we want to use are
             pimonidazole with multiplex immunohistochemistry and single cell RNA sequencing.
  
        The information we get from the tests will help us get a better understanding of how myeloma
        works. Future studies may also use these results to develop new kinds of drugs for myeloma.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Qualitative assessment of the utility of a set of investigational tools for investigating the bone marrow microenvironment in myeloma patients
  time frame: Assessment is at the time of diagnosis.
  description: Specifically we aim to determine the feasibility of using pimonidazole as a marker of hypoxia in conjunction with: A) Multiplex immunohistochemistry to characterise the spatial organization of cellular inflammatory elements and myeloma cells in the bone marrow, B)Single cell RNA sequencing to characterise the expression profile of myeloma cells in hypoxic areas of marrow
  arm group label: Basic science study, no intervention.
  description: Basic science study, no intervention.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Emma Searle, MBChB, MA, MRCP, FRCPath, PhD
  role: Principal Investigator
  affiliation: University of Manchester, The Christie NHS Foundation Trust
  last name: Adam Jones, MBBS, MSc, MRCP
  phone: +44 161 276 1234
  email: adam.jones35@nhs.net
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  mesh term: Hypoxia
  sharing ipd: No
  ipd description: Individual patient level data is unlikely to be useful to other groups in this small pilot study.