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Clinical Trials/NCT03819829
NCT03819829
Recruiting
Not Applicable

Blood Sampling of Healthy Volunteers for Immunological Research

The Netherlands Cancer Institute1 site in 1 country50 target enrollmentFebruary 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Volunteers
Sponsor
The Netherlands Cancer Institute
Enrollment
50
Locations
1
Primary Endpoint
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
Status
Recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 5, 2019
End Date
December 2, 2027
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Immunophenotyping of both myeloid and lymphoid cells in healthy individuals(assessed up to 12 months)

Study Sites (1)

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