New assays need to be validated before they can be implemented in research or in the clinic. The validation of assays consists of several steps. First a proof of principle must be performed to determine whether the assay is capable of measuring the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Iron disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint for this study is storage of blood from healthy
volunteers to use in the validation of an ERFE assay.
Secondary outcome
The use of the stored plasma and serum for the validation of assays in the
field of iron metabolism in the next 10 years.
Background summary
The research of the Radboudumc Expertise Center for Iron disorders focuses on
the understanding of the iron metabolism, in particular the identification and
characterization of novel factors that affect dysregulation of iron homeostasis
in various human disorders among which are some of the world's most prevalent
diseases such as iron deficiency, anemia of chronic (kidney) disease,
hereditary hemochromatosis, inherited (iron loading) anemias, and malarial
infections. New findings are translated into novel diagnostic assays and
therapeutic strategies that can be implemented in the clinic.
Study objective
New assays need to be validated before they can be implemented in research or
in the clinic. The validation of assays consists of several steps. First a
proof of principle must be performed to determine whether the assay is capable
of measuring the specific protein the assays is targeted at. It indicates
whether the assay is biologically plausible. Samples used usually consist of
patient samples and samples from healthy volunteers. The assay is biologically
plausible when a difference in outcome in patient samples and samples from
healthy volunteers can be measured.
Secondly, the assay has to be analytically validated. This is done by measuring
several analytical characteristics of the assay e.g linearity, accuracy and
precision.
Lastly a biological validation of the assay has to be performed. This test
determines the biological plausibility of the assay and (often) shows the
correlation between the protein of interest and other parameters. Patient
samples and samples from healthy volunteers are often used for these test.
As described above, samples from healthy volunteers are needed in several steps
of the validation process of an assay. The material of healthy volunteers can
also be used to get a first impression of reference values (of what is
considered healthy). These references values are important in daily practice
since they can serve as a diagnostic tool. The importance of samples from
healthy volunteers is therefore undeniable during these type of studies.
Study design
The study is an observational study with invasive measurements. The invasive
measurement in this study is the obtaining of blood from healthy volunteers.
The blood withdrawal will be performed according to standard procedures of the
radboudumc hospital. The processing and storage of the blood will be performed
according to the protocol of the radboud biobank. This protocol is attached
under the name C1.protocolbijlageSOPbiobank.1.03042018
Study burden and risks
The risk of blood drawing is low, but there is a chance of unsolicited
findings. The parameters that are tested are parameters concerning the iron
metabolism e.g. EPO, hepcidin, soluble transferrin receptor and ERFE. Deviating
results could be found during these tests. Volunteers will be informed when
unsolicited findings are made.
The benefit of these studies are validated diagnostic tests and a first
impression of reference values.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Participants need to be healthy volunteers between 18 and 55 years old. They should live in the Netherlands and preferably in the area of Nijmegen. People who are diagnosed with any iron disorder can not participate in this study. Examples of Iron disorders are anemia, β-thalassaemia, hemochromatosis and IRIDA. Also people that use any sort of medication can not participate, however the use of contraceptive pills is allowed.
Exclusion criteria
If deviant iron parameter values are found in samples of the healthy volunteers they will be excluded from the study.
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 | NL65219.091.18 |