NIEHS Repository of Stored Biological Samples for Future Use

NCT05666739 | Recruiting

• 2 other identifiers: 10001073001073-E
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Physiology

Keywords

Blood; Urine; Assay Development; Natural History

Outcome Measures

Primary Outcomes (1)

• 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...

  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.

  On-going

Study Arms (1)

healthy controls

General public population, including females and males, who are over the age of 18, with a mixture of races and ethnicities representative of North Carolina

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The general community sample will be from Durham, Raleigh, Chapel Hill and other nearby cities close to the NIEHS Clinical Research Unit (CRU).

You may qualify if:

• To be eligible to participate in this study, an individual must meet all the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Ability to provide informed consent.
• Male or female, aged \>=18
• Able to travel to the NIEHS CRU for study visits

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Not willing to have samples stored for future use.
• Any condition that, in the investigator s opinion, places the participant at undue risk for complications associated with required study procedures.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Lawrence S Kirschner, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347; myniehs@nih.gov

Lawrence S Kirschner, M.D.

CONTACT

(984) 287-3562; lawrence.kirschner@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: December 28, 2022
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 19, 2032
• Study Completion (Estimated): July 19, 2032
• Last Updated: June 11, 2026

Record last verified: 2026-06-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)