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 - NCT00995891-20892(Clinical Trial 369219)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Bethesda |
|
State:
|
|
MD |
| Zip Code: |
|
20892 |
| Conditions: |
|
Healthy |
| Purpose: |
|
Background:
- 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.
Objective:
- To obtain blood, urine, buccal (mouth) mucosa, and bone marrow samples from healthy
volunteers.
Eligibility:
- Healthy individuals at least 8 years of age.
Design:
- Volunteers will be recruited through the Program for Healthy Volunteers, Patient
Recruitment and Public Liaison Office, or self-referral through the clinicaltrials.gov
Web site.
- Health will be confirmed by a brief history and physical examination and blood work.
- Volunteers 8 years of age and older will provide blood and urine samples using standard
procedures. Buccal mucosa samples will be obtained by scraping the insides of both
cheeks with a sterile nylon brush.
- Bone marrow samples will be obtained from volunteers 18 years of age and older by
taking two aspirates from the posterior iliac crest (an area near the hip).
- Samples will be assigned a unique code and will be stored until they are no longer of
scientific value or the volunteer withdraws consent for their use....
|
| Study summary: |
|
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) 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 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. |
| Criteria: |
|
- INCLUSION CRITERIA:
- Healthy volunteer (health status confirmed by brief History and Physical Exam and
blood work)
- Age 8 years and older (no upper limit) for blood, urine, and buccal mucosa sampling
Or
Ages 18 years or older (no upper limit) for bone marrow sampling and/or leukapheresis
cells
Or
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
- Able to comprehend the investigational nature of the protocol and provide informed
consent (If the healthy volunteer is a minor, the minor's parent or guardian must provide
consent and the minor must be able to provide assent)
EXCLUSION CRITERIA:
- Healthy volunteers and/or pregnant woman with diseases with an inflammatory or immune
component
- Subjects with active infections requiring systemic antibiotic therapy
- Persons who are alcoholic or abusers of illicit substances |
|
|
|
| Study is available at: |
|
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|