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 | Completed

• 2 other identifiers: 09022909-H-0229
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Laboratory Research Specimens; Biologic Samples; Sample Collection; Tissue Procurement; HV; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Mechanism for collecting samples

  One time point

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Angelique Biancotto, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: September 9, 2009
• Study Completion: September 5, 2018
• Last Updated: December 5, 2019

Record last verified: 2018-09-05

Locations

US (1)