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
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 8 - Any |
| Updated: | 3/27/2019 |
| Start Date: | September 9, 2009 |
| End Date: | September 5, 2018 |
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
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, normal tissue and bone marrow samples and/or
leukopheresis cells 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).
- Normal tissue samples will be obtained from volunteers 18 years of age and older by
taking superficial skin samples (punch biopsies)
- Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and
older to obtain white blood cells for research
- 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....
- 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, normal tissue and bone marrow samples and/or
leukopheresis cells 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).
- Normal tissue samples will be obtained from volunteers 18 years of age and older by
taking superficial skin samples (punch biopsies)
- Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and
older to obtain white blood cells for research
- 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....
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.
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.
- 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 or normal tissue 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)
- Must be willing to allow samples to undergo genetic studies.
EXCLUSION CRITERIA:
- Healthy volunteers and/or pregnant women 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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