- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02810613
Leiden University Medical Center Mini Donor Bank
August 28, 2017 updated by: Meta Roestenberg, Leiden University Medical Center
(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 Overview
Status
Withdrawn
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy human volunteers
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2016
Primary Completion (Actual)
May 31, 2016
Study Completion (Actual)
May 31, 2016
Study Registration Dates
First Submitted
May 31, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (Estimate)
June 23, 2016
Study Record Updates
Last Update Posted (Actual)
August 29, 2017
Last Update Submitted That Met QC Criteria
August 28, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mini Donor Bank
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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