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Recruiting

NCT Number: NCT03819829

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.

Recruiting

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Key information

Conditions

Healthy Volunteers

Age range

36 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NKI-AVL

Amsterdam, 1066CX, Netherlands

Location status: Recruiting

Location contact

L Voorwerk, MD

CONTACT

[email protected]

M Kok, MD

CONTACT

[email protected]

M Kok, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Blood sample

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

    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

  1. Immunophenotyping of both myeloid and lymphoid cells in healthy individuals

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

L Voorwerk, MD

CONTACT

[email protected]

3120512 ext. 9111

M Kok, MD

CONTACT

[email protected]

3120512 ext. 9111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2019
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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