<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/NCT03262311</url>
  </required_header>
  <id_info>
    <org_study_id>CCR4770</org_study_id>
    <nct_id>NCT03262311</nct_id>
  </id_info>
  <brief_title>Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours</brief_title>
  <official_title>Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Cancer Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Cancer Research, United Kingdom</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 purpose of this study is to test the potential of a relatively simple serum assay that&#xD;
      aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be&#xD;
      compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to&#xD;
      gain (predictive value) from the addition of radiation sensitiser drugs or targeted&#xD;
      radiotherapy dose escalation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: To analyse tiny cancer cell fragments called extracellular vesicles isolated from blood&#xD;
      samples for their ability to identify patients with tumours that are relatively&#xD;
      oxygen-starved and expected to be resistant to ionising radiation and many chemotherapy&#xD;
      drugs.&#xD;
&#xD;
      Participants: 16 patients with proven cancer plus 4 healthy volunteers who give written&#xD;
      informed consent to participate will be included in the study.&#xD;
&#xD;
      Recruitment: Eligible patients will be identified in the Outpatient Department at The Royal&#xD;
      Marsden in Sutton or London and given a copy of the Information Sheet describing the study in&#xD;
      detail. Dr Somaiah's team will call these potential volunteers at least 24 hours after they&#xD;
      have received written information about the study to answer any questions. The same consent&#xD;
      process will be followed for staff members who agree to participate as healthy volunteers.&#xD;
      Research subjects who offer verbal agreement to participate will be asked for written consent&#xD;
      and will be allocated a study ID. This will be used on all trial documentation and blood&#xD;
      samples together with their initials and date of data/sample collection.&#xD;
&#xD;
      Pimonidazole administration: This well-established drug has the valuable property of binding&#xD;
      exclusively to oxygen- starved tissues in a form that can be detected as a colour change in&#xD;
      cell fragments released into the blood stream. A single oral dose of pimonidazole 500 mg/m2&#xD;
      will be prescribed and administered in a Royal Marsden outpatient clinic after confirmation&#xD;
      of eligibility and completion of written informed consent. A member of the research team will&#xD;
      monitor subjects to ensure that the prescribed drug is successfully taken (swallowed with&#xD;
      water) before leaving the hospital (or going back to work/home in the case of healthy&#xD;
      volunteers).&#xD;
&#xD;
      Blood sample: A peripheral venous blood sample of 20 ml will be collected from each&#xD;
      participant the day after administration of pimonidazole, since it takes several hours for&#xD;
      the drug to be absorbed and to bind to proteins and other molecules in oxygen-starved cells.&#xD;
      A second sample will be collected 14 ±5 days later in order to confirm that all coloured cell&#xD;
      fragments have disappeared from the circulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Actual">September 12, 2019</completion_date>
  <primary_completion_date type="Actual">September 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detectable pimonidazole staining</measure>
    <time_frame>24 hours and 2 weeks (+/- 5 days)</time_frame>
    <description>Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Hypoxia marker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of a single dose of the hypoxia marker Pimonidazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypoxia marker</intervention_name>
    <description>Single oral dose of pimonidazole 500 mg/m2</description>
    <arm_group_label>Hypoxia marker</arm_group_label>
    <other_name>Pimonidazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients i) Age ≥18 years ii) Biopsy-proven invasive carcinomas of head and neck, lung,&#xD;
        bladder, uterine cervix or breast iii) Bulky (≥4 cm or ≥ 30 cc) primary/locally recurrent&#xD;
        tumour or regional node masses iv) No clinical evidence of distant metastases unless&#xD;
        oligometastases (ie distant relapse in only a limited number of regions for which local&#xD;
        ablative therapy could be curative) v) Patient due for surgery, radiotherapy, systemic&#xD;
        therapy or no anti-cancer treatment vi) Written informed consent&#xD;
&#xD;
        Healthy volunteers i) Age ≥18 years ii) Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients i) Inadequate cognitive ability to undertake the appropriate informed consent&#xD;
        procedure&#xD;
&#xD;
        Healthy volunteers i) Past history of cancer, apart from non-melanomatous skin cancer or in&#xD;
        situ carcinoma uterine cervix&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Navita Somaiah</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Cancer Research, United Kingdom</affiliation>
  </overall_official>
  <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>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</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>Hypoxia</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/NCT03262311
org study id: CCR4770
nct id: NCT03262311
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the potential of a relatively simple serum assay that
      aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be
      compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to
      gain (predictive value) from the addition of radiation sensitiser drugs or targeted
      radiotherapy dose escalation.
Aim: To analyse tiny cancer cell fragments called extracellular vesicles isolated from blood
      samples for their ability to identify patients with tumours that are relatively
      oxygen-starved and expected to be resistant to ionising radiation and many chemotherapy
      drugs.

      Participants: 16 patients with proven cancer plus 4 healthy volunteers who give written
      informed consent to participate will be included in the study.

      Recruitment: Eligible patients will be identified in the Outpatient Department at The Royal
      Marsden in Sutton or London and given a copy of the Information Sheet describing the study in
      detail. Dr Somaiah's team will call these potential volunteers at least 24 hours after they
      have received written information about the study to answer any questions. The same consent
      process will be followed for staff members who agree to participate as healthy volunteers.
      Research subjects who offer verbal agreement to participate will be asked for written consent
      and will be allocated a study ID. This will be used on all trial documentation and blood
      samples together with their initials and date of data/sample collection.

      Pimonidazole administration: This well-established drug has the valuable property of binding
      exclusively to oxygen- starved tissues in a form that can be detected as a colour change in
      cell fragments released into the blood stream. A single oral dose of pimonidazole 500 mg/m2
      will be prescribed and administered in a Royal Marsden outpatient clinic after confirmation
      of eligibility and completion of written informed consent. A member of the research team will
      monitor subjects to ensure that the prescribed drug is successfully taken (swallowed with
      water) before leaving the hospital (or going back to work/home in the case of healthy
      volunteers).

      Blood sample: A peripheral venous blood sample of 20 ml will be collected from each
      participant the day after administration of pimonidazole, since it takes several hours for
      the drug to be absorbed and to bind to proteins and other molecules in oxygen-starved cells.
      A second sample will be collected 14 ±5 days later in order to confirm that all coloured cell
      fragments have disappeared from the circulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Detectable pimonidazole staining
time frame: 24 hours and 2 weeks (+/- 5 days)
description: Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole
arm group label: Hypoxia marker
arm group type: Experimental
description: Administration of a single dose of the hypoxia marker Pimonidazole
intervention type: Other
intervention name: Hypoxia marker
description: Single oral dose of pimonidazole 500 mg/m2
arm group label: Hypoxia marker
other name: Pimonidazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Navita Somaiah
role: Principal Investigator
affiliation: Institute of Cancer Research, United Kingdom
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypoxia