The current study is designed to validate the secondary reference material identified in the previous study, and to produce a larger batch of this new calibrator for harmonization of worldwide hepcidin assays the next 5 years. For that reason, our…
ID
Source
Brief title
Condition
- Iron and trace metal metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are:
1. Commutability of the secondary reference material;
2. An inter-assay CV of <10% obtained with a mathematical simulated
harmonization - with results of the reference material measured by assays with
an intra-assay CV of < 8.0%;
3. Stability of the reference material for 5 years;
4. Production of ~2600 vials of 350 µl reference material for long term
international use on a "fee for service basis".
Secondary outcome
Not applicable.
Background summary
Serum hepcidin holds great promise as target of therapy and biomarker for
diagnosis and monitoring of iron disorders. Currently, large differences are
found in absolute hepcidin levels measured by different assays. To facilitate
use of hepcidin in clinical practice and research, equivalence between hepcidin
assays needs to be improved, which can be achieved by harmonization (i.e.when
results are equivalent by being traceable to a secondary reference material).
By developing an international, commutable* (secondary) calibrator for
different hepcidin assays, this study will contribute to harmonization. This
will facilitate: i) determination and application of general accepted reference
intervals and clinical decision-limits and ii) comparison and pooling of data
obtained from different studies. This will improve research and clinical
translation in this field.
A previous harmonization study investigated different types of reference
materials. Lyophilized, native (heparin) plasma with cryolyoprotectant CLP5
(increases stability) showed to be commutable and therefore suitable as
international calibrator for hepcidin assays. Our hypothesis is that
lyophilized, native serum with CLP5 will also be commutable and therefore
suitable as international secondary reference material for harmonization of
hepcidin assays worldwide.
* Commutable means that the reference material and native patient samples will
behave similar in different assays.
Study objective
The current study is designed to validate the secondary reference material
identified in the previous study, and to produce a larger batch of this new
calibrator for harmonization of worldwide hepcidin assays the next 5 years. For
that reason, our objective is:
* Will lyophilized native serum with CLP5 also be suitable as international
secondary reference material for harmonization of worldwide hepcidin assays to
obtain equivalent results for clinical samples regardless of the assay used.
And if so;
* Is it possible to produce enough secondary reference material for
harmonization of hepcidin assays worldwide, that will be stable for the next 5
years.
Study design
Biomarker assay harmonization study; an international send-out of human serum
for an one-time measurement with 11 different assays at 10 different
laboratory.
Study burden and risks
Hemochromatosis patients are treated with phlebotomies. For this study, we aim
to use this blood (which otherwise will be destroyed). These patients will not
be subjected to extra interventions than their regular treatment.
Volunteers will be subjected to a venipuncture twice. Depending on their serum
hepcidin and ferritin concentrations which will be determined through a
pre-screening (bloodcollection of 3 ml), either 300 ml or 50 ml blood will be
collected during the second puncture. The risks concerning this venipuncture
will be minimal.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
All phlebotomy patients that we can include within 2 weeks and healthy volunteers. Both age between 20-65 years. They should not be HIV, hepatitis B or hepatitis C positive.
Exclusion criteria
To prevent induction of hypoferremia (shortage of iron), no blood will be collected for the second time for volunteers with a ferritin concentration of < 40 µg/L, and max. 50 ml blood will be collected for volunteers with a ferritin concentration between 40 - 70 µg/L.
The blood of all subjects will be tested for HIV, hepatitis B and hepatitis C. A subject will be excluded if they appear to be positive for one of these three.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56910.091.16 |