Sample Collection From Healthy Volunteers for Assay Optimization
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|ClinicalTrials.gov Identifier: NCT03538600|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : May 27, 2020
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.
To collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin/mucosal swabs.
Healthy people ages 18-80
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|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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, 2027|
- 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. ]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. There is no specified outcome.
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
|Contact: Laura E Failla, C.R.N.P.||(240) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Rachel D Sparks, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|