<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/NCT03800446</url>
  </required_header>
  <id_info>
    <org_study_id>Ferritin POC</org_study_id>
    <nct_id>NCT03800446</nct_id>
  </id_info>
  <brief_title>Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood</brief_title>
  <acronym>FerPOC</acronym>
  <official_title>Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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>
      Measurement of iron is important for identifying both low and high iron levels in the body.&#xD;
      Measuring a protein in the blood called ferritin is currently the easiest way to determine a&#xD;
      patient's iron status. However, the test requires a blood sample that is be sent to the&#xD;
      laboratory for measurement, which can cause delays in obtaining the result. The investigators&#xD;
      are testing whether a point of care device that measures ferritin levels using a capillary&#xD;
      blood sample is accurate compared to current methods of testing. This could allow measurement&#xD;
      of ferritin immediately in the clinic with only a drop of blood, and enable treatment&#xD;
      decisions based on these results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2019</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</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>
    <intervention_model_description>Prospective cohort diagnostic study design</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Point of care ferritin detection accuracy</measure>
    <time_frame>Within 12 hours of standard testing</time_frame>
    <description>The proportion of subjects where the difference between the two different methods is less than 15; this will be measured by calculating the difference between the two results.&#xD;
The proportion for the absolute difference between the two measurement methods on the same subject that is less than 15 ng/mL will be calculated. Non-inferiority test for one proportion will be performed to examine, if, the proportion is greater than 95%, where the test p value and the one-sided 97.5% confidence interval will be reported.&#xD;
An interim analysis will be performed after the first 50 subjects are enrolled to test the assumptions made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distribution of the differences between ferritin level as measured by the standard test and POC test</measure>
    <time_frame>Within 12 hours of standard testing</time_frame>
    <description>Distribution of the differences between the two measurement methods using the normality test, mean difference and its 95% CI, and outlier detection; other methods may be used as appropriate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design</measure>
    <time_frame>Within 12 hours of standard testing</time_frame>
    <description>Applies to patients who have multiple measurement points during study follow-up. The differences in ferritin levels between the two methods will be studied using a mixed model to account for the between-subject variation and the within-subject variation. The mean difference and its 95% CI, the Bonferroni-adjusted p-values and the plot of mean vs time will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agreement between testing methods in patients who have been assessed at least twice</measure>
    <time_frame>Within 12 hours of standard testing</time_frame>
    <description>Applies only to patients with at least two repeated measures. Agreement between the two measurement methods will be quantified and summarized using probability of agreement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy of the new measurement method</measure>
    <time_frame>Within 12 hours of standard testing</time_frame>
    <description>The Receiver Operating Characteristic curves (ROC) analysis will be performed to report the diagnostic accuracy for the new measurement method. The optimal cut-off value and the associated accuracy measures (sensitivity, specificity, predictive values and etc.) will be reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anemia, Iron Deficiency</condition>
  <condition>Iron Overload</condition>
  <condition>Iron-deficiency</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point of care ferritin test</intervention_name>
    <description>Point of care test that uses capillary blood sample from finger to determine ferritin level</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to read and understand English (the consent form is in English)&#xD;
&#xD;
          -  attending ambulatory hematology clinic and/or outpatient medical care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>December 17, 2019</last_update_submitted>
  <last_update_submitted_qc>December 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Michelle Zeller</investigator_full_name>
    <investigator_title>Assistant Professor; Department of Medicine, Director Operations; Hamilton Regional Laboratory Medicine Program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Iron Overload</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/NCT03800446
org study id: Ferritin POC
nct id: NCT03800446
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measurement of iron is important for identifying both low and high iron levels in the body.
      Measuring a protein in the blood called ferritin is currently the easiest way to determine a
      patient's iron status. However, the test requires a blood sample that is be sent to the
      laboratory for measurement, which can cause delays in obtaining the result. The investigators
      are testing whether a point of care device that measures ferritin levels using a capillary
      blood sample is accurate compared to current methods of testing. This could allow measurement
      of ferritin immediately in the clinic with only a drop of blood, and enable treatment
      decisions based on these results.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort diagnostic study design
primary purpose: Diagnostic
masking: None (Open Label)
measure: Point of care ferritin detection accuracy
time frame: Within 12 hours of standard testing
description: The proportion of subjects where the difference between the two different methods is less than 15; this will be measured by calculating the difference between the two results.
The proportion for the absolute difference between the two measurement methods on the same subject that is less than 15 ng/mL will be calculated. Non-inferiority test for one proportion will be performed to examine, if, the proportion is greater than 95%, where the test p value and the one-sided 97.5% confidence interval will be reported.
An interim analysis will be performed after the first 50 subjects are enrolled to test the assumptions made.
measure: Distribution of the differences between ferritin level as measured by the standard test and POC test
time frame: Within 12 hours of standard testing
description: Distribution of the differences between the two measurement methods using the normality test, mean difference and its 95% CI, and outlier detection; other methods may be used as appropriate
measure: Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design
time frame: Within 12 hours of standard testing
description: Applies to patients who have multiple measurement points during study follow-up. The differences in ferritin levels between the two methods will be studied using a mixed model to account for the between-subject variation and the within-subject variation. The mean difference and its 95% CI, the Bonferroni-adjusted p-values and the plot of mean vs time will be reported.
measure: Agreement between testing methods in patients who have been assessed at least twice
time frame: Within 12 hours of standard testing
description: Applies only to patients with at least two repeated measures. Agreement between the two measurement methods will be quantified and summarized using probability of agreement.
measure: Diagnostic accuracy of the new measurement method
time frame: Within 12 hours of standard testing
description: The Receiver Operating Characteristic curves (ROC) analysis will be performed to report the diagnostic accuracy for the new measurement method. The optimal cut-off value and the associated accuracy measures (sensitivity, specificity, predictive values and etc.) will be reported.
arm group label: Intervention
arm group type: Other
description: All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).
intervention type: Diagnostic Test
intervention name: Point of care ferritin test
description: Point of care test that uses capillary blood sample from finger to determine ferritin level
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Michelle Zeller
investigator title: Assistant Professor; Department of Medicine, Director Operations; Hamilton Regional Laboratory Medicine Program
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Iron Overload
sharing ipd: No