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The Self Sampling Study

Feasibility of measuring blood based neuro-degenerative biomarkers using at-home sampling in a patient population - Self-Sampling Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58452
Enrollment
200
Registered
2025-06-25
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS) and Alzheimers Disease (AD) MS and Alzheimer's Disease

Interventions

n.v.t.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: General inclusioncriteria (Everyone):The participant must be willing and mentally competent of providing written informed consent prior to study entry. The participant must be 18 years or older.   Specific inlcusioncriteria per participant group:Healthy controls:The participant has no known cognitive abnormalities (no memory complaints that the participant worries about).People with Alzheimer’s Disease:The participant has a confirmed biological diagnosis of (early-stage) Alzheimer’s disease.This diagnosis is established through CSF Abeta42 analysis or amyloid PET imaging.The participant does not yet show extensive clinical symptoms of the disease.People with Multiple Sclerosis (MS):The participant has a clinical diagnosis of MS based on consultation with a neurologist. 

Exclusion criteria

Exclusion criteria: The participant is 17 years old or younger. The participant has a significant diagnosed bleeding disorderThe participant is currently taking anticoagulant or antiplatelet medication that could interfere with blood collection or increase risk of complications. The participant has a contra-indication for venipuncture The participant is uncomfortable with (self-)sampling of blood.  

Design outcomes

Primary

MeasureTime frame
In this study the feasibility of testing for neurodegenerative biomarkers using multiple capillary self-sampling devices is determined. The primary parameters are: Correlation between different blood samples taken with capillary self-sampling devices and venous blood sample is examined using statistics. Intra-individual variability of the biomarkers over 5 days is determined. This helps determine stability of biomarkers in capillary samples and sampling methods. 

Secondary

MeasureTime frame
The effect of pre-analytics on the biomarker levels is examined.  The quality of each self-acquired sample is inspected and analytically determined, similar to a previous study. After completion of multiple self-samplings using various devices, the participant satisfaction is measured for each used device with a questionnaire. The overall receivability of the device is determined based on these results and incorporated in the device evaluation together with the success rate of sampling per device. 

Countries

Netherlands

Contacts

Public ContactF.I. van der Zee

Amsterdam UMC

f.i.vanderzee@amsterdamumc.nl0204440302

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026