- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03800446
Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood (FerPOC)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample).
|
Point of care test that uses capillary blood sample from finger to determine ferritin level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Within 12 hours of standard testing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 12 hours of standard testing
|
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.
|
Within 12 hours of standard testing
|
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.
|
Within 12 hours of standard testing
|
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.
|
Within 12 hours of standard testing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ferritin POC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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