NIEHS Repository of Stored Biological Samples for Future Use

Normal Physiology Clinical Trial

Official title:

NIEHS Repository of Stored Biological Samples for Future Use

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666739
• Other study ID #: 10001073
• Secondary ID: 001073-E
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: July 19, 2032

Study information

• Verified date: November 8, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NIEHS Join A Study Recruitment Group
• Phone: (855) 696-4347
• Email: myniehs[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: July 19, 2032
• Est. primary completion date: July 19, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Normal Physiology

Locations

Country	Name	City	State
United States	NIEHS Clinical Research Unit (CRU)	Research Triangle Park	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page