RECRUITING

Sample Collection From Healthy Volunteers for Assay Optimization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 3-80 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.

Official Title

Sample Collection From Healthy Volunteers for Assay Optimization

Quick Facts

Study Start:2018-06-28
Study Completion:2043-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03538600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 3-80 years.
  2. 2. Able to provide informed consent (for ages \>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 years).
  3. 3. Agree to allow biological samples to be stored for future research.
  4. 4. Willing to provide blood, stool, saliva, skin/mucosal/tonsil swabs, and/or skin punch biopsy specimens.
  1. 1. Pregnancy.
  2. 2. History of autoimmune or autoinflammatory disease.
  3. 3. Diabetes mellitus.
  4. 4. Cancer chemotherapy within the past 5 years.
  5. 5. Currently receiving treatment for an active malignancy.
  6. 6. Surgery within the past 8 weeks.
  7. 7. History of recent (within the past 30 days) infection.
  8. 8. History of significant, active parasitic, amebic, fungal, or mycobacterial infections within the past 5 years (as determined by the PI).
  9. 9. Infected with HIV and/or hepatitis B and/or C.
  10. 10. Use of an oral or inhaled glucocorticoid within the past 30 days.
  11. 11. History of a bleeding disorder.
  12. 12. Screening lab values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
  13. 13. Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.
  14. 14. Receipt of a live-attenuated vaccine within the past 30 days.
  15. 15. Receipt of any other type of vaccine within the past 14 days.
  16. 16. Current or past use (within the past 90 days) of immunoglobulin therapy.
  17. 17. Current use of illicit drugs (per subject report).
  18. 18. Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
  19. 19. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).
  20. 20. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
  21. 21. Any condition that, in the opinion of the PI, contraindicates participation in this study or would significantly affect immune profile.

Contacts and Locations

Study Contact

Laura E Failla, C.R.N.P.
CONTACT
(240) 669-5323
laura.failla@nih.gov
Kalpana Manthiram, M.D.
CONTACT
(301) 529-4787
kalpana.manthiram@nih.gov

Principal Investigator

Kalpana Manthiram, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Kalpana Manthiram, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-28
Study Completion Date2043-06-30

Study Record Updates

Study Start Date2018-06-28
Study Completion Date2043-06-30

Terms related to this study

Keywords Provided by Researchers

  • Blood
  • Microbiome Analysis
  • Stool
  • Saliva
  • Skin
  • Natural History

Additional Relevant MeSH Terms

  • Healthy Volunteers