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NCT03819829 Clinical Trial

Blood Sampling of Healthy Volunteers for Immunological Research

Healthy Volunteers Clinical Trial

Official title:
Blood Sampling of Healthy Volunteers for Immunological Research

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03819829
Other study ID # B18HIR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2019
Est. completion date December 2, 2027

Study information
Verified date March 2023
Source The Netherlands Cancer Institute
Contact M Kok, MD
Phone 3120512
Email m.kok@nki.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

In order to properly compare the immunobiology of healthy volunteers to (advanced) cancer patients, the investigators use age-matched controls with no history of cancer and no potentially interfering medication. Healthy volunteers will be asked to donate 5 tubes of blood

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2, 2027
Est. primary completion date December 2, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Fever 14 days before blood withdrawal - Donated blood for the same program within the last 2 years - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample
Blood sample

Locations
Country Name City State
Netherlands NKI-AVL Amsterdam

Sponsors (1)
Lead Sponsor Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Immunophenotyping of both myeloid and lymphoid cells in healthy individuals Immunophenotyping of both myeloid and lymphoid cells in healthy controls to gain insights in immunological defects and immune evasion in cancer patients assessed up to 12 months
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