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Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood (FerPOC)

Primary Purpose

Anemia, Iron Deficiency, Iron Overload, Iron-deficiency

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Point of care ferritin test
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anemia, Iron Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • able to read and understand English (the consent form is in English)
  • attending ambulatory hematology clinic and/or outpatient medical care

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Intervention

    Arm Description

    All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).

    Outcomes

    Primary Outcome Measures

    Point of care ferritin detection accuracy
    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.

    Secondary Outcome Measures

    Distribution of the differences between ferritin level as measured by the standard test and POC test
    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
    Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design
    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.
    Agreement between testing methods in patients who have been assessed at least twice
    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.
    Diagnostic accuracy of the new measurement method
    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.

    Full Information

    First Posted
    December 12, 2018
    Last Updated
    December 17, 2019
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03800446
    Brief Title
    Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
    Acronym
    FerPOC
    Official Title
    Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    April 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Iron Deficiency, Iron Overload, Iron-deficiency

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective cohort diagnostic study design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Other
    Arm 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(s)
    Point of care ferritin test
    Intervention Description
    Point of care test that uses capillary blood sample from finger to determine ferritin level
    Primary Outcome Measure Information:
    Title
    Point of care ferritin detection accuracy
    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.
    Time Frame
    Within 12 hours of standard testing
    Secondary Outcome Measure Information:
    Title
    Distribution of the differences between ferritin level as measured by the standard test and POC test
    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
    Time Frame
    Within 12 hours of standard testing
    Title
    Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design
    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.
    Time Frame
    Within 12 hours of standard testing
    Title
    Agreement between testing methods in patients who have been assessed at least twice
    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.
    Time Frame
    Within 12 hours of standard testing
    Title
    Diagnostic accuracy of the new measurement method
    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.
    Time Frame
    Within 12 hours of standard testing

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: able to read and understand English (the consent form is in English) attending ambulatory hematology clinic and/or outpatient medical care Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood

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