Clincosm LogoSign in Get a demo

NIEHS Repository of Stored Biological Samples for Future Use

Sponsor
National Institute of Environmental Health Sciences (NIEHS) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
NCT05666739
Collaborator
(none)
2,000
Enrollment
1
Location
113.4
Anticipated Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    NIEHS Repository of Stored Biological Samples for Future Use
    Anticipated Study Start Date :
    Feb 6, 2023
    Anticipated Primary Completion Date :
    Jul 19, 2032
    Anticipated Study Completion Date :
    Jul 19, 2032

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    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... [On-going]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NIEHS Clinical Research Unit (CRU) Research Triangle Park North Carolina United States 27709

    Sponsors and Collaborators

    • National Institute of Environmental Health Sciences (NIEHS)

    Investigators

    • Principal Investigator: Stavros Garantziotis, M.D., National Institute of Environmental Health Sciences (NIEHS)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Environmental Health Sciences (NIEHS)
    ClinicalTrials.gov Identifier:
    NCT05666739
    Other Study ID Numbers:
    • 10001073
    • 001073-E
    First Posted:
    Dec 28, 2022
    Last Update Posted:
    Feb 1, 2023
    Last Verified:
    Dec 21, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Environmental Health Sciences (NIEHS)
    Blood
    Urine
    Assay Development
    Natural History

    Study Results

    No Results Posted as of Feb 1, 2023