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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00995891
Other study ID # 090229
Secondary ID 09-H-0229
Status Completed
Phase
First received
Last updated
Start date September 9, 2009
Est. completion date September 5, 2018

Study information

Verified date September 5, 2018
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date September 5, 2018
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years and older
Eligibility - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mechanism for collecting samples One time point
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