Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00995891
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date October 14, 2009
First Posted Date October 15, 2009
Last Update Posted Date November 5, 2019
Study Start Date September 9, 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: June 4, 2014)
Mechanism for collecting samples [ Time Frame: One time point ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00995891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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 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
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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Healthy Volunteers
Intervention Not Provided
Study Groups/Cohorts 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 Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 31, 2017)
88
Original Enrollment
 (submitted: October 14, 2009)
9999999
Study Completion Date September 5, 2018
Primary Completion Date Not Provided
Eligibility 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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00995891
Other Study ID Numbers 090229
09-H-0229
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Angelique Biancotto, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 5, 2018