NIEHS Repository of Stored Biological Samples for Future Use

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.

Study Overview

• Status: Recruiting
• Conditions: Normal Physiology

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: NIEHS Join A Study Recruitment Group; Phone Number: (855) 696-4347; Email: myniehs@nih.gov
• Study Contact Backup: Name: Lawrence S Kirschner, M.D.; Phone Number: (984) 287-3562; Email: lawrence.kirschner@nih.gov

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • Recruiting
      • NIEHS Clinical Research Unit (CRU)
      • Contact: NIEHS Join A Study Recruitment Group; Phone Number: 855-696-4347; Email: myniehs@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

• 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

EXCLUSION CRITERIA:

Exclusion Criteria for prospective biospecimen collection:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Not willing to have samples stored for future use.
2. Any condition that, in the investigator s opinion, places the participant at undue risk for complications associated with required study procedures.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Lawrence S Kirschner, M.D., National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): July 19, 2032
• Study Completion (Estimated): July 19, 2032

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 5, 2025

More Information

Terms related to this study

• Keywords: Natural History; Urine; Blood; Assay Development
• Other Study ID Numbers: 10001073; 001073-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No