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Trial record 17 of 633 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT03800446
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Zeller, McMaster University

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.

Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Iron Overload Iron-deficiency Diagnostic Test: Point of care ferritin test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cohort diagnostic study design
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Intervention
All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).
Diagnostic Test: Point of care ferritin test
Point of care test that uses capillary blood sample from finger to determine ferritin level




Primary Outcome Measures :
  1. Point of care ferritin detection accuracy [ Time Frame: Within 12 hours of standard testing ]

    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 :
  1. Distribution of the differences between ferritin level as measured by the standard test and POC test [ Time Frame: Within 12 hours of standard testing ]
    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

  2. 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 ]
    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.

  3. Agreement between testing methods in patients who have been assessed at least twice [ Time Frame: Within 12 hours of standard testing ]
    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.

  4. Diagnostic accuracy of the new measurement method [ Time Frame: Within 12 hours of standard testing ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800446


Contacts
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Contact: Michelle Zeller, MD 905-521-2100 ext 73928 zeller@mcmaster.ca
Contact: Erin Jamula 905-525-9140 ext 26800 jamulae@mcmaster.ca

Sponsors and Collaborators
McMaster University

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Responsible Party: Michelle Zeller, Assistant Professor; Department of Medicine, Director Operations; Hamilton Regional Laboratory Medicine Program, McMaster University
ClinicalTrials.gov Identifier: NCT03800446     History of Changes
Other Study ID Numbers: Ferritin POC
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Iron Overload
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases