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NIEHS Repository of Stored Biological Samples for Future Use

NIEHS Repository of Stored Biological Samples for Future Use

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05666739
Enrollment
2000
Registered
2022-12-28
Start date
2024-07-15
Completion date
2032-07-19
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Physiology

Keywords

Blood, Urine, Assay Development, Natural History

Brief summary

Background: Laboratory tests that use blood and urine can provide a great deal of information about human health and disease. To develop even better tests and to improve the ways samples are handled for testing researchers need to experiment with samples from healthy people. Objective: This natural history study will collect blood and urine from healthy people. The samples will build a repository that will be used for all kinds of research. Eligibility: Healthy people aged 18 years or older. Design: Participants will have 1 study visit. The visit will last up to 2 hours. Participants will be screened. They will answer questions about their health history. They will list any medications they take. They will consent to donate samples for research and future use: Blood: Up to 4.5 tablespoons of blood may be collected from a needle inserted into a vein. Urine: Participants will be given a sterile container to provide a sample. Some participants may be asked to provide other types of samples. Some participants may be asked to provide new samples if their first ones are depleted.

Detailed description

Study Description: We aim to build a repository utilizing both prospectively and retrospectively collected human biological samples, like blood and urine, to develop and test the following: specific laboratory assays, to develop and maintain freezer and specimen handling quality control, to have blinded quality control specimens for laboratory testing, and to assess exposure variability over time. Objectives: Primary Objective: To build a repository for approved investigators to access stored biological samples for the following: developing and testing specific laboratory assays, to maintain freezer and specimen handling quality control, to have blinded quality control specimens for testing labs, and to assess exposure variability over time.

Interventions

None listed

Sponsors

National Institute of Environmental Health Sciences (NIEHS)
Lead SponsorNIH

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: Inclusion Criteria for prospective biospecimen collection: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Ability to provide informed consent. 3. Male or female, aged \>=18 4. Able to travel to the NIEHS CRU for study visits

Design outcomes

Primary

MeasureTime frameDescription
To build a repository for approved investigators to access stored biological samples for the following: developing and testing specific laboratory assays, to maintain freezer and specimen handling quality control, to have blinded quality control...On-goingTo build a repository for approved investigators to access stored biological samples for the following: developing and testing specific laboratory assays, to maintain freezer and specimen handling quality control, to have blinded quality control specimens for testing labs, and to assess exposure variability over time.

Countries

United States

Contacts

CONTACTNIEHS Join A Study Recruitment Group
myniehs@nih.gov(855) 696-4347
CONTACTLawrence S Kirschner, M.D.
lawrence.kirschner@nih.gov(984) 287-3562
PRINCIPAL_INVESTIGATORLawrence S Kirschner, M.D.

National Institute of Environmental Health Sciences (NIEHS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026