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
|Condition or disease||Intervention/treatment||Phase|
|Anemia, Iron Deficiency Iron Overload Iron-deficiency||Diagnostic Test: Point of care ferritin test||Not Applicable|
|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)|
|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|
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
- 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.
- 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
- 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.
- 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.
- 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.
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
|Contact: Michelle Zeller, MD||905-521-2100 ext email@example.com|
|Contact: Erin Jamula||905-525-9140 ext firstname.lastname@example.org|