Anemia, Iron DeficiencyFerPOCNCT03800446
Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
A study testing Point of care ferritin test in people with Anemia, Iron Deficiency and Iron Overload, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency, Iron Overload, Iron-deficiency
- What is being tested?
- Point of care ferritin test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to read and understand English (the consent form is in English)
- attending ambulatory hematology clinic and/or outpatient medical care
Who cannot join
- -
About this study
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.
- Conditions
- Anemia, Iron Deficiency, Iron Overload, Iron-deficiency
- Being tested
- Point of care ferritin test
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ferritin testDiagnostic test
Point of care test that uses capillary blood sample from finger to determine ferritin level
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample). Receives: Diagnostic Test: Point of care ferritin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 hours of standard testing
Secondary outcomes (4)
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
Measured: 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
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.
Measured: Within 12 hours of standard testing
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.
Measured: Within 12 hours of standard testing
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.
Measured: Within 12 hours of standard testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study startSep 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort diagnostic study design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Zeller, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800446
- Sponsor's protocol ID
- Ferritin POC
- Acronym
- FerPOC
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2018
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
- ClinicalTrials.gov ID
- NCT03800446
- Acronym / sponsor ID
- FerPOC / Ferritin POC
- Conditions
- Anemia, Iron Deficiency, Iron Overload, Iron-deficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort diagnostic study design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Diagnostic Test: Point of care ferritin testAll patients will undergo testing with the study intervention (point of care) and routine testing with serum ferritin (venous blood sample). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to read and understand English (the consent form is in English)
- attending ambulatory hematology clinic and/or outpatient medical care
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care ferritin testPoint of care test that uses capillary blood sample from finger to determine ferritin level | Diagnostic test | Intervention |
Primary outcome
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.
4 secondary outcomes
Distribution of the differences between ferritin level as measured by the standard test and POC test
Time frame: 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
Agreement between testing methods in patients who have been assessed at least twice
Time frame: Within 12 hours of standard testing
Diagnostic accuracy of the new measurement method
Time frame: Within 12 hours of standard testing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Anemia, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care ferritin test in people with Anemia, Iron Deficiency and Iron Overload, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point of care ferritin detection accuracy (time frame: Within 12 hours of standard testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.