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

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:

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

Exclusion Criteria:

  1. Previous vasovagal collapse during venepuncture.
  2. For female participants: pregnancy or lactation.
  3. 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.
  4. Chronic use of immunosuppressive drugs.
  5. 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.

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

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.

Clinical Trials on Diabetes

3
Subscribe