To validate analytical parameters of blood-based biomarker methods and assess the influence of pre-analytical blood handling on levels of those biomarkers.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood material will be processed immediately after collection to create sample
sets. Each sample set will be handled differently according to a strict
pre-defined experimental set-ups. These sample sets can then be used to study
technical parameters of laboratory methods and to study stability of specific
proteins upon different pre-analytical sample handling procedures. Study
endpoint is the qualification of laboratory methods and the decision for an
optimal pre-analytical sample handling protocol per potential biomarker of
interest.
Secondary outcome
not applicable
Background summary
In the Neurochemistry laboratory of the Amsterdam UMC, location VUmc, work
continuously focusses on identifying new biomarkers, and developing and
qualifying methods to quantify those new biomarkers. When determining if a
potential biomarker relates to disease status, also technical validation
experiments have to take place. New laboratory methods have to be validated by
screening for quality, accuracy, precision and robustness. Additionally,
stability of the protein of interest in blood upon pre-analytical sample
handling procedures has to be carefully validated. Pre-analytical sample
handling covers the complete process from blood collection in the optimal tube
type, the conditions of tube centrifugation, the process of dividing the sample
in smaller aliquot tubes, the freezer storage conditions and (multiple times)
thawing of samples for biomarkers. The Neurochemistry lab already showed the
importance of pre-analytical sample handling standardization in CSF. These
technical and pre-analytical validation aspects of biomarker discovery research
should also be done in blood, therefore fresh blood material is required.
Study objective
To validate analytical parameters of blood-based biomarker methods and assess
the influence of pre-analytical blood handling on levels of those biomarkers.
Study design
Adults (> 18 years of age) who present at the department of Clinical Chemistry
(VUmc) for any diagnostic blood collection or who present at the Alzheimer
center Amsterdam where they donate blood for storage in the Amsterdam Dementia
Biobank will be asked for consent to participate in this study. Following their
venipuncture, additional blood will be collected. Total volume of the combined
collection for diagnostics/biobanking and our study will never exceed 70
milliliters.
Study burden and risks
There will be no significant burden or additional risk to the volunteers. The
volunteer will donate additional blood via the venipuncture that is already
performed for the diagnostic/biobanking blood collection. There are no extra
visits necessary. Total volume of the combined collection for
diagnostics/biobanking and our study will never exceed 70 milliliters. There
are no personal benefits of participation for the volunteer.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Adults aged > 18 years.
Exclusion criteria
Non-adults aged < 18 years.
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 | NL69123.029.19 |