<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/NCT02234453</url>
  </required_header>
  <id_info>
    <org_study_id>MO14/11295</org_study_id>
    <nct_id>NCT02234453</nct_id>
  </id_info>
  <brief_title>Home Testing of Blood Counts in Chemotherapy Patients</brief_title>
  <official_title>A Phase 1 Trial Assessing the Safety and Performance of the Minicare H-2000 in Home Testing of Blood Counts in Chemotherapy Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesise that cancer patients on systemic anticancer therapy can measure&#xD;
      a home blood count, temperature, record qualitative data and transfer the results&#xD;
      electronically to the hospital clinical team.&#xD;
&#xD;
      A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic&#xD;
      anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis. Neutrophil&#xD;
      count is usually obtained by venepuncture by a health-care professional. The Minicare H-2000&#xD;
      is a new device which facilitates home self-testing of blood count, temperature and symptoms.&#xD;
      The four components are i) blood count recorder using a capillary sample obtained via&#xD;
      finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting patient-reported&#xD;
      outcomes and iv) secure communication through the 3G network.&#xD;
&#xD;
      The investigators propose a single-centre, non-randomised feasibility study to test the&#xD;
      process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood&#xD;
      count readings, temperature and qualitative data electronically to the hospital clinical&#xD;
      team. The aim is to test training of patients to use a finger-prick method of obtaining blood&#xD;
      count, patient ability to perform the test, retention of training, the ability of the&#xD;
      Minicare H-2000 to facilitate the data transfer and to test the secondary care interface.&#xD;
      This study will provide preliminary data on the potential of Minicare H-2000 to prevent&#xD;
      wasted hospital journeys when the blood count has not recovered sufficiently for subsequent&#xD;
      SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80&#xD;
      patients to this study which will be performed in addition to current local standard of care.&#xD;
&#xD;
      This study enables identification of suboptimal areas of the process prior to investigating&#xD;
      the application of the minicare H-2000 within oncology to improve the clinical patient&#xD;
      pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to&#xD;
      reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys&#xD;
      and hospital resources, reduce non-elective hospital admissions and personalise delivery of&#xD;
      SACT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of home tested blood count results transferred to the hospital team on the day of the venous blood test performed prior to the subsequent SACT cycle</measure>
    <time_frame>15-42 days after training, dependent on length of chemotherapy cycle, most commonly 22 days.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of home tested temperature and questionnaire responses transferred to the hospital after (i) initial home training (TP1), (ii) forty-eight hours (TP2) and (iii) on the day of venous blood test pre subsequent SACT cycle (TP3).</measure>
    <time_frame>15-42 days from training, dependent on length of chemotherapy cycle, most commonly 22 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient feedback on willingness to use and ease of use of Minicare H-2000.</measure>
    <time_frame>15 to 42 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess proportion of successful tests performed with subsequent cycles.</measure>
    <time_frame>up to 9 months. Most common maximum of 4.5 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-care professional feedback on server clinical interface.</measure>
    <time_frame>15-42 days, dependent on lenghtof chemotherapy cycle, most commonly 22 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of capillary granulocyte count with venous laboratory measured neutrophil count pre subsequent SACT cycle.</measure>
    <time_frame>15 to 42 days, dependent on chemotherapy cycle length, most commonly 22 days.</time_frame>
    <description>Accuracy of the Minicare H-2000 granulocyte measuring technology will be confirmed using Pearson's correlation co-effcient and R squared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of home tested blood count results transferred to the hospital team after (i) initial home training (TP1), (ii) forty-eight hours (TP2)</measure>
    <time_frame>24 to 48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Cancer patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients with solid tumours receiving systemic anti-cancer therapy who are able to use the Minicare H-2000.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Minicare H-2000</intervention_name>
    <description>Patients will use the Minicare H-2000 at home to measure their capillary blood count, temperature, record questionnaire results and transfer the results via the 3G network to the hospital team.</description>
    <arm_group_label>Cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any solid tumour diagnosis being managed by either medical or clinical oncologists.&#xD;
&#xD;
          -  Patients receiving one or more systemic chemotherapy drugs or targeted therapy at&#xD;
             Leeds Cancer Centre.&#xD;
&#xD;
          -  Adults ≥ 18 years.&#xD;
&#xD;
          -  Live within boundaries of Local Care Direct service provision.&#xD;
&#xD;
          -  Live in post-code with good 2G, 3G or GPRS connectivity according to coverage map.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On hormone treatment only for their cancer.&#xD;
&#xD;
          -  Participating in the active phase of a therapeutic clinical trial.&#xD;
&#xD;
          -  Inability to give informed consent due to mental capacity or language barrier.&#xD;
&#xD;
          -  Patient or carer unable or unlikely to be able to perform fine manipulation required&#xD;
             to use lancet or cartridge to obtain capillary blood sample and result.&#xD;
&#xD;
          -  Known inherited or acquired bleeding disorder.&#xD;
&#xD;
          -  History of haematological malignancy.&#xD;
&#xD;
          -  Known poorly controlled anti-coagulation (INR&gt;3.0 within 6 months)&#xD;
&#xD;
          -  Prisoner in custody of HM Prison Service.&#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>Geoff Hall, PhD, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Geoff Hall, PhD, FRCP</last_name>
    <phone>0113 206 8970</phone>
    <email>G.Hall@leeds.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>St James's Teaching Hospital, Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Geoff Hall, PhD, FRCP</last_name>
      <phone>0113 2068970</phone>
      <email>G.Hall@leeds.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Elaine Dunwoodie, MB ChB</last_name>
      <email>e.h.dunwoodie@leeds.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Geoff Hall, PhD, FRCP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Dr Geoff Hall</investigator_full_name>
    <investigator_title>Senior Lecturer &amp; Honorary Consultant in Medical Oncology</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>home</keyword>
  <keyword>blood count</keyword>
  <keyword>remote</keyword>
  <!-- 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/NCT02234453
org study id: MO14/11295
nct id: NCT02234453
lead sponsor: 
collaborator: 
has dmc: No
The investigators hypothesise that cancer patients on systemic anticancer therapy can measure
      a home blood count, temperature, record qualitative data and transfer the results
      electronically to the hospital clinical team.

      A low neutrophil blood cell count (neutropenia) can be a dose-limiting toxicity of systemic
      anti-cancer therapy (SACT) and can be life-threatening when complicated by sepsis. Neutrophil
      count is usually obtained by venepuncture by a health-care professional. The Minicare H-2000
      is a new device which facilitates home self-testing of blood count, temperature and symptoms.
      The four components are i) blood count recorder using a capillary sample obtained via
      finger-prick ii) Bluetooth linked thermometer iii) tele-hub collecting patient-reported
      outcomes and iv) secure communication through the 3G network.

      The investigators propose a single-centre, non-randomised feasibility study to test the
      process of patients on chemotherapy using the Minicare H-2000 to deliver self-tested blood
      count readings, temperature and qualitative data electronically to the hospital clinical
      team. The aim is to test training of patients to use a finger-prick method of obtaining blood
      count, patient ability to perform the test, retention of training, the ability of the
      Minicare H-2000 to facilitate the data transfer and to test the secondary care interface.
      This study will provide preliminary data on the potential of Minicare H-2000 to prevent
      wasted hospital journeys when the blood count has not recovered sufficiently for subsequent
      SACT cycles. The investigators intend to obtain informed consent to recruit between 30 to 80
      patients to this study which will be performed in addition to current local standard of care.

      This study enables identification of suboptimal areas of the process prior to investigating
      the application of the minicare H-2000 within oncology to improve the clinical patient
      pathway. The investigators ongoing intentions are to trial the use of the Minicare H-2000 to
      reduce frequency and severity of neutropenic complications, prevent wasted hospital journeys
      and hospital resources, reduce non-elective hospital admissions and personalise delivery of
      SACT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of home tested blood count results transferred to the hospital team on the day of the venous blood test performed prior to the subsequent SACT cycle
time frame: 15-42 days after training, dependent on length of chemotherapy cycle, most commonly 22 days.
measure: Proportion of home tested temperature and questionnaire responses transferred to the hospital after (i) initial home training (TP1), (ii) forty-eight hours (TP2) and (iii) on the day of venous blood test pre subsequent SACT cycle (TP3).
time frame: 15-42 days from training, dependent on length of chemotherapy cycle, most commonly 22 days.
measure: Patient feedback on willingness to use and ease of use of Minicare H-2000.
time frame: 15 to 42 days
measure: Assess proportion of successful tests performed with subsequent cycles.
time frame: up to 9 months. Most common maximum of 4.5 months.
measure: Health-care professional feedback on server clinical interface.
time frame: 15-42 days, dependent on lenghtof chemotherapy cycle, most commonly 22 days.
measure: Correlation of capillary granulocyte count with venous laboratory measured neutrophil count pre subsequent SACT cycle.
time frame: 15 to 42 days, dependent on chemotherapy cycle length, most commonly 22 days.
description: Accuracy of the Minicare H-2000 granulocyte measuring technology will be confirmed using Pearson's correlation co-effcient and R squared.
measure: Proportion of home tested blood count results transferred to the hospital team after (i) initial home training (TP1), (ii) forty-eight hours (TP2)
time frame: 24 to 48 hours
arm group label: Cancer patients
arm group type: Experimental
description: Adult patients with solid tumours receiving systemic anti-cancer therapy who are able to use the Minicare H-2000.
intervention type: Device
intervention name: Minicare H-2000
description: Patients will use the Minicare H-2000 at home to measure their capillary blood count, temperature, record questionnaire results and transfer the results via the 3G network to the hospital team.
arm group label: Cancer patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geoff Hall, PhD, FRCP
role: Principal Investigator
affiliation: University of Leeds
last name: Geoff Hall, PhD, FRCP
phone: 0113 206 8970
email: G.Hall@leeds.ac.uk
facility: 
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Dr Geoff Hall
investigator title: Senior Lecturer & Honorary Consultant in Medical Oncology