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Withdrawn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
About this trial
This is an interventional diagnostic trial for Anemia, Iron Deficiency
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:
-
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
NCT ID
NCT03800446
First Posted
December 12, 2018
Last Updated
December 17, 2019
Sponsor
McMaster University
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
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Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
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