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
|First Received Date ICMJE||October 14, 2009|
|Last Updated Date||June 25, 2014|
|Start Date ICMJE||September 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Mechanism for collecting samples [ Time Frame: One time point ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00995891 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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 ICMJE||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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Healthy Volunteers|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||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.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||99999999|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00995891|
|Other Study ID Numbers ICMJE||090229, 09-H-0229|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP