NCT02543996 Human Biospecimen Procurement Protocol: Biorepository to Support Translational Research to Identify Disease Mechanism(s)
| NCT ID | NCT02543996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Undiagnosed Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2015-09-17 |
| Primary Completion | 2040-06-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2015-09-17 with a primary completion date of 2040-06-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Studies show that rare genetic variants might lead to diseases. Researchers want to collect blood and tissue samples so they can study them and better understand diseases. Objective: To collect blood and tissue samples for studies to identify underlying causes of disease. Eligibility: People of all ages Design: Participants will have blood and/or tissue samples collected. Samples can be collected at the NIH Clinical Center. Participants doctors can collect the samples and send them to NIH. NIH staff can collect samples off site. For blood samples, blood is taken from an arm vein using a needle. Tissue collection may involve: Buccal smear: Cells are collected by scraping the inside of the cheek with a cotton swab. Saliva collection: Participants spit into a cup. Skin biopsy: A special needle takes a very small skin sample. Surgical waste tissue: If participants have surgery, NIH may receive samples of tissue that would routinely be removed. Umbilical cord or cord blood collection: If a participant has a baby, NIH may receive a small piece of the umbilical cord or blood from the cord once the baby is delivered. ...
Eligibility Criteria
* INCLUSION CRITERIA (SUBJECTS MUST MEET ONE OF THE FOLLOWING): * Age: older than 1 month of age * Affected pregnant women if they have been referred with a known or suspected pathology or if they become pregnant while on study. * Unaffected related pregnant women (including spouses/partners) for cord blood and tissue collection (surgical waste) only at the time of delivery. * Cognitively impaired individuals that are affected * Cognitively impaired individuals that are related to an affected subject. * Subjects willing to provide informed consent. EXCLUSION CRITERIA: * Healthy volunteers unable to give informed consent * Cognitively impaired individuals who are not affected * Cognitively impaired individuals who are not related to affected subjects.
Contact & Investigator
Manfred Boehm, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT02543996 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 100 Years, studying Undiagnosed Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02543996 currently recruiting?
Yes, NCT02543996 is actively recruiting participants. Contact the research team at ruth.brower@nih.gov for enrollment information.
Where is the NCT02543996 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02543996 clinical trial?
NCT02543996 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Manfred Boehm, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 10,000 participants.