Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
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|ClinicalTrials.gov Identifier: NCT00995891|
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : November 5, 2019
|First Submitted Date||October 14, 2009|
|First Posted Date||October 15, 2009|
|Last Update Posted Date||November 5, 2019|
|Study Start Date||September 9, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Mechanism for collecting samples [ Time Frame: One time point ]|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00995891 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies|
|Official Title||Collection of Blood, Bone Marrow, Skin Biopsies and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols Laboratory Research Studies|
- Laboratory research studies require control samples from healthy volunteers to compare with samples from patients. These studies will help researchers better understand and refine treatments for immune system and inflammatory diseases.
- To obtain blood, urine, buccal (mouth) mucosa, normal tissue and bone marrow samples and/or leukopheresis cells from healthy volunteers.
- Healthy individuals at least 8 years of age.
The purpose of this protocol is to collect blood (ages 8 and older), urine (ages 8 and older), buccal mucosa samples (ages 8 and older), normal tissue (ages18 and older) bone marrow (ages 18 and older) and/or leukapheresis cells (ages 18 and older) from healthy volunteers, including pregnant women (ages 18 and older, blood and/or buccal mucosa only). To be enrolled on this study, pregnant women must not carry the diagnosis of an immune-mediated or inflammatory disease, or have signs or symptoms of an immune or inflammatory disease; otherwise they may be eligible for participation on CHI protocol 10-H-0162 in the affected adult cohort. Samples will be used as controls for clinical and translational research in the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI). These control samples are indispensable for many of our laboratory research projects, including understanding the pathophysiology of a wide variety of immune-mediated and inflammatory diseases.
The primary objective is to provide a mechanism for collection, tracking, storing, dispensing, analyzing and disposing of these laboratory research samples from healthy volunteers.
There is no primary endpoint.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||September 5, 2018|
|Primary Completion Date||Not Provided|
Ages 18 years or older (no upper limit) for bone marrow or normal tissue sampling and/or leukapheresis cells
Pregnant women (health status confirmed by brief History and Physical Exam and blood work) must be 18 years or older (no upper limit) for blood and/or buccal mucosa sampling
|Ages||8 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||090229
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 5, 2018|