Blood Sampling of Healthy Volunteers for Immunological Research
1 other identifier
interventional
50
1 country
1
Brief Summary
This protocol will be used to collect crucial components of the immune system from healthy volunteers for the characterization of immune cells in fresh blood. A pipeline has been set up for comprehensive immune phenotyping of both lymphoid and myeloid cells within 24 hours after blood withdrawal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
Started Feb 2019
Longer than P75 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
February 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 2, 2027
March 23, 2023
March 1, 2023
7.8 years
December 13, 2018
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The number of immune cells, both lymphoid and myeloid, present in the blood of healthy individuals, assessed by flow cytometry, as well as cytokine expression and transcriptome profiles of these cells
the number of lymphoid and myeloid immune cells present in the blood of healthy individuals using flow cytometry, assessing the cytokine expression of these cells in healthy individuals using ELISA cytokine assays, and assessing gene expression of these cells using single cell transcriptomics analyses using droplet-based single cell RNA sequencing.
assessed up to 12 months
Secondary Outcomes (1)
Immunophenotyping of both myeloid and lymphoid cells in healthy individuals
assessed up to 12 months
Study Arms (1)
Blood sample
OTHERBlood sample
Interventions
Eligibility Criteria
You may qualify if:
- Age above 35 years
- Written informed consent
- No history of cancer
- No use of systemic immunosuppressive medication (eg. corticosteroids). Local use of corticosteroids (eg. topical or inhalation) is allowed.
You may not qualify if:
- Fever 14 days before blood withdrawal
- Donated blood for the same program within the last 2 years
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NKI-AVL
Amsterdam, 1066CX, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M Kok, MD
NKI-AvL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
January 29, 2019
Study Start
February 5, 2019
Primary Completion (Estimated)
December 2, 2026
Study Completion (Estimated)
December 2, 2027
Last Updated
March 23, 2023
Record last verified: 2023-03