Blood Sampling of Healthy Volunteers for Immunological Research

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Other: Blood sample

• Registration Number: NCT03819829
• Lead Sponsor: The Netherlands Cancer Institute

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.

Detailed 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

Study Timeline

• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-29
• Study Start: 2019-02-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2026-12-02
• Study Completion: 2027-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Blood sample	Blood sample

Primary Outcome Measures

Name	Time	Method
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	assessed up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Immunophenotyping of both myeloid and lymphoid cells in healthy individuals	assessed up to 12 months	Immunophenotyping of both myeloid and lymphoid cells in healthy controls to gain insights in immunological defects and immune evasion in cancer patients

Trial Locations

Locations (1)

NKI-AVL; 🇳🇱 Amsterdam, Netherlands