MalariaNCT02810613
Leiden University Medical Center Mini Donor Bank
An observational study of Malaria and Schistosoma Mansoni, run by Leiden University Medical Center.
Trial summary
(Bio)medical research, particularly immunological, metabolic, transcriptional or biological assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Schistosoma Mansoni, Schistosoma Haematobium
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2016to 31 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy human volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
(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.
- Conditions
- Malaria, Schistosoma Mansoni, Schistosoma Haematobium, Diabetes, Asthma
- Medical subject headings
- Malaria, Schistosomiasis, Schistosomiasis haematobia, Diabetes Mellitus, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start31 May 2016
- Primary completion31 May 2016
- Study completion31 May 2016
Why it stopped: Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Roestenberg, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810613
- Sponsor's protocol ID
- Mini Donor Bank
- Status last verified
- Aug 2017
- First submitted
- 31 May 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leiden University Medical Center Mini Donor Bank
- ClinicalTrials.gov ID
- NCT02810613
- Acronym / sponsor ID
- Mini Donor Bank
- Conditions
- Malaria, Schistosoma Mansoni, Schistosoma Haematobium, Diabetes, Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy human volunteers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Schistosoma Mansoni, run by Leiden University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A collection of samples for the purpose of (bio)medical laboratory assays including immunological, metabolic, transcriptional or biological analyses. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.