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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02810613
Other study ID # Mini Donor Bank
Secondary ID
Status Withdrawn
Phase N/A
First received May 31, 2016
Last updated August 28, 2017
Start date May 31, 2016
Est. completion date May 31, 2016

Study information

Verified date August 2017
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 31, 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Leiden University Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary A collection of samples for the purpose of (bio)medical laboratory assays including immunological, metabolic, transcriptional or biological analyses. 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
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