Blood Sampling of Healthy Volunteers for Immunological Research

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Blood sample

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066CX
    • Recruiting
    • NKI-AvL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood sample	Other: Blood sample; Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Anticipated): December 2, 2026
• Study Completion (Anticipated): December 2, 2027

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: B18HIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: to be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No