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Clinical Trials/NCT02810613
NCT02810613WithdrawnNot Applicable

Leiden University Medical Center Mini Donor Bank

Leiden University Medical Center0 sitesStarted: May 31, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Primary Endpoint
A collection of samples for the purpose of (bio)medical laboratory assays including immunological, metabolic, transcriptional or biological analyses.

Study Overview

Brief Summary

(Bio)medical research, particularly immunological, metabolic, transcriptional or biological assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine. In order to comply with international guidelines for Good Clinical Practice, the investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or urine from voluntary donors. Recruitment of volunteers will be a continuous process. Volunteers will consent to occasional blood- or urine donation.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Subject is aged ≥ 18 and ≤ 65 years and in good health.
  • •Subject has adequate understanding of the procedures of the study.
  • •Subject is able to communicate well with the investigator.
  • •Subject has signed informed consent.
  • •Subject refrains from donation to the Sanquin blood bank.

Exclusion Criteria

  • •Previous vasovagal collapse during venepuncture.
  • •For female participants: pregnancy or lactation.
  • •Presence of any chronic systemic condition, which could compromise the health of the volunteer when performing venepuncture or interfere with the interpretation of immunological or metabolic test results.
  • •Chronic use of immunosuppressive drugs.
  • •Total blood volume donated exceeding >500 mL in the past 4 months.

Outcomes

Primary Outcomes

A collection of samples for the purpose of (bio)medical laboratory assays including immunological, metabolic, transcriptional or biological analyses.

Time Frame: 10 years

collection of samples for the purpose of biomedical assays, e.g. biobanking of samples for different assays, each one of which has a separate objective

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Leiden University Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meta Roestenberg

MD, PhD

Leiden University Medical Center

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