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Leiden University Medical Center Mini Donor Bank

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ClinicalTrials.gov Identifier: NCT02810613
Recruitment Status : Withdrawn (Study never started.)
First Posted : June 23, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Meta Roestenberg, Leiden University Medical Center

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.

Condition or disease
Malaria Schistosoma Mansoni Schistosoma Haematobium Diabetes Asthma

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Other
Actual Study Start Date : May 31, 2016
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : May 31, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Blood and urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy human volunteers
Criteria

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.
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Responsible Party: Meta Roestenberg, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02810613    
Other Study ID Numbers: Mini Donor Bank
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases