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Trial record 67 of 327 for:    NIAID | Recruiting Studies

Sample Collection From Healthy Volunteers for Assay Optimization

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ClinicalTrials.gov Identifier: NCT03538600
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

The Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available.

Objective:

To collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin/mucosal swabs.

Eligibility:

Healthy people ages 18-80

Design:

Participants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests.

If the results of the screening are normal, participants will be asked to give one or more of these samples:

Blood will be drawn from an arm vein with a needle and syringe.

Mucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina.

Participants will spit into a tube to collect saliva.

Participants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions.

Over the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour.

About every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C.


Condition or disease
Normal Physiology

Detailed Description:
The Laboratory of Immune System Biology plays a major role in fostering the growth of systems biology efforts across the National Institutes of Health, in large measure through its development of new tools for high-throughput data generation and complex systems modeling. The lab's experimental component requires ongoing assay development and optimization, which depend on the availability of human biological samples for testing. The primary purpose of this protocol is to obtain biological specimens from healthy volunteers to support the lab s development and optimization of scientific assays.The secondary objective of this study is to track immunologic changes over time using the assays developed and optimized in this study.

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sample Collection From Healthy Volunteers for Assay Optimization
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2028

Group/Cohort
1
healthy volunteers



Primary Outcome Measures :
  1. The purpose of this study is to collect biological specimens (blood, stool, saliva, and/or skin/mucosal swabs) for the development and optimization of scientific assays. [ Time Frame: Throughout the study. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
biological specimens from healthy volunteers
Criteria
  • INCLUSION CRITERIA:

    1. Age 18-80 years.
    2. Able to provide informed consent.
    3. Agree to allow biological samples to be stored for future research.
    4. Willing to provide blood, stool, saliva, and/or skin/mucosal swabs.

EXCLUSION CRITERIA:

  1. Pregnancy.
  2. History of autoimmune or autoinflammatory disease.
  3. Diabetes mellitus.
  4. Cancer chemotherapy within the past 5 years.
  5. Currently receiving treatment for an active malignancy.
  6. Surgery within the past 8 weeks.
  7. History of recent (within the past 30 days) infection.
  8. History of parasitic, amebic, fungal or mycobacterial infections within the past 5 years.
  9. Infected with HIV and/or hepatitis B and/or C.
  10. Use of an oral glucocorticoid within the past 30 days.
  11. History of a bleeding disorder.
  12. Complete blood count with differential and/or acute care panel values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the principal investigator (PI).
  13. Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.
  14. Receipt of a live-attenuated vaccine within the past 30 days.
  15. Receipt of any other type of vaccine within the past 14 days.
  16. Current or past use (within the past 90 days) of immunoglobulin therapy.
  17. Current use of illicit drugs (per subject report).
  18. Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
  19. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).
  20. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
  21. Any condition that, in the opinion of the PI, contraindicates participation in this study.

Co-enrollment guidelines: Participants may be co-enrolled in other studies with the approval of the PI.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538600


Contacts
Contact: Laura E Failla, C.R.N.P. (240) 669-5323 laura.failla@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Rachel D Sparks, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03538600     History of Changes
Other Study ID Numbers: 180101
18-I-0101
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 26, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Blood
Microbiome Analysis
Stool
Saliva
Skin