<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/NCT03265158</url>
  </required_header>
  <id_info>
    <org_study_id>CCR4595</org_study_id>
    <nct_id>NCT03265158</nct_id>
  </id_info>
  <brief_title>Blood Immunophenotyping in Staging of Indolent B-cell Lymphomas V1.0</brief_title>
  <acronym>BMPB</acronym>
  <official_title>Evaluation of Peripheral Blood (PB) Immunophenotyping in the Detection of Bone Marrow Involvement in Cases of Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL).</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>
      To determine whether peripheral blood flow cytometry can reduce or replace invasive bone&#xD;
      marrow examinations in patients with slow growing lymphomas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine whether peripheral blood flow cytometry can reduce or replace&#xD;
      invasive bone marrow examinations in patients with slow growing lymphomas.&#xD;
&#xD;
      Patients with certain types of slow growing (indolent) lymphomas, including the most common&#xD;
      sub-type, follicular lymphoma, require a bone marrow examination for staging of their&#xD;
      lymphoma. This provides prognostic information and can be important for planning treatment.&#xD;
      However, despite the use of local anaesthetic, and in some cases sedation, bone marrow&#xD;
      examinations can cause pain and discomfort to patients. Complications are rare but include&#xD;
      risk of bleeding, infection and even nerve damage.&#xD;
&#xD;
      Flow cytometry of peripheral blood samples can detect low levels of circulating lymphoma&#xD;
      cells. A previous study has demonstrated that detection of lymphoma cells by peripheral blood&#xD;
      flow cytometry has a good correlation with bone marrow involvement. This study will seek to&#xD;
      find if this correlation is evident in a larger, statistically significant patient cohort.&#xD;
      Depending on the study results, invasive and painful bone marrow procedures could potentially&#xD;
      be reduced or eliminated in patients with certain slow growing lymphomas. Patients diagnosed&#xD;
      with follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma and being treated at&#xD;
      the Royal Marsden NHS Foundation Trust will be eligible for this study. Participation in the&#xD;
      study will require one peripheral blood sample to be taken before the patient's routine bone&#xD;
      marrow biopsy. The study is expected to last between 2 - 3 years for data collection of 108&#xD;
      samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2020</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>Positive predictive value of PB flow cytometry compared to BM</measure>
    <time_frame>3 years</time_frame>
    <description>The primary outcome measure for this study is the positive predictive value of peripheral blood flow cytometry when compared with bone marrow biopsy in determining bone marrow involvement in patients with FL, MCL and MZL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value of PB flow cytometry compared to BM</measure>
    <time_frame>3 years</time_frame>
    <description>The secondary outcome measures for this study are negative predictive value, sensitivity and specificity of peripheral blood flow cytometry when compared with bone marrow biopsy in determining bone marrow involvement in patients with FL, MCL and MZL.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Follicular Lymphoma (FL)</condition>
  <condition>Mantle Cell Lymphoma (MCL)</condition>
  <condition>Marginal Zone Lymphoma (MZL)</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone&#xD;
        lymphoma (MZL).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals ≥18yrs of age&#xD;
&#xD;
          -  Able to provide informed written consent&#xD;
&#xD;
          -  Patients with a diagnosis of follicular lymphoma, marginal zone lymphoma and mantle&#xD;
             cell lymphoma requiring staging or re-staging as part of clinical management&#xD;
&#xD;
          -  pre-transplant bone marrow assessment&#xD;
&#xD;
          -  High grade transformation associated with the above lymphomas will be allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a histological diagnosis other than those mentioned above or those&#xD;
             diagnosed with 2 or more different lymphomas, excluding transformed lymphoma.&#xD;
&#xD;
          -  Patients not fit enough to undergo bone marrow examination.&#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>Sunil Iyengar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haematology Consulant, The Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorna Smith</last_name>
    <phone>020 8915 6187</phone>
    <email>lorna.smith2@rmh.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Surrey</state>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorna Smith</last_name>
      <phone>020 8915 6187</phone>
      <email>lorna.smith2@rmh.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Alysha Malik</last_name>
      <phone>020 8642 6011</phone>
      <email>alysha.malik@rmh.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Sunil Iyengar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>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>Lorna Smith</last_name>
      <phone>020 8915 6187</phone>
    </contact>
    <contact_backup>
      <last_name>Alysha Malik</last_name>
      <phone>020 8642 6011</phone>
      <email>alysha.malik@rmh.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Sunil Iyengar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 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</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, B-Cell, Marginal Zone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03265158
org study id: CCR4595
nct id: NCT03265158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine whether peripheral blood flow cytometry can reduce or replace invasive bone
      marrow examinations in patients with slow growing lymphomas.
This study will determine whether peripheral blood flow cytometry can reduce or replace
      invasive bone marrow examinations in patients with slow growing lymphomas.

      Patients with certain types of slow growing (indolent) lymphomas, including the most common
      sub-type, follicular lymphoma, require a bone marrow examination for staging of their
      lymphoma. This provides prognostic information and can be important for planning treatment.
      However, despite the use of local anaesthetic, and in some cases sedation, bone marrow
      examinations can cause pain and discomfort to patients. Complications are rare but include
      risk of bleeding, infection and even nerve damage.

      Flow cytometry of peripheral blood samples can detect low levels of circulating lymphoma
      cells. A previous study has demonstrated that detection of lymphoma cells by peripheral blood
      flow cytometry has a good correlation with bone marrow involvement. This study will seek to
      find if this correlation is evident in a larger, statistically significant patient cohort.
      Depending on the study results, invasive and painful bone marrow procedures could potentially
      be reduced or eliminated in patients with certain slow growing lymphomas. Patients diagnosed
      with follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma and being treated at
      the Royal Marsden NHS Foundation Trust will be eligible for this study. Participation in the
      study will require one peripheral blood sample to be taken before the patient's routine bone
      marrow biopsy. The study is expected to last between 2 - 3 years for data collection of 108
      samples.
observational model: Other
time perspective: Prospective
measure: Positive predictive value of PB flow cytometry compared to BM
time frame: 3 years
description: The primary outcome measure for this study is the positive predictive value of peripheral blood flow cytometry when compared with bone marrow biopsy in determining bone marrow involvement in patients with FL, MCL and MZL.
measure: Negative predictive value of PB flow cytometry compared to BM
time frame: 3 years
description: The secondary outcome measures for this study are negative predictive value, sensitivity and specificity of peripheral blood flow cytometry when compared with bone marrow biopsy in determining bone marrow involvement in patients with FL, MCL and MZL.
peripheral blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sunil Iyengar
role: Principal Investigator
affiliation: Haematology Consulant, The Royal Marsden NHS Foundation Trust
last name: Lorna Smith
phone: 020 8915 6187
email: lorna.smith2@rmh.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, B-Cell, Marginal Zone
sharing ipd: No