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| ID | Type | Description | Link |
|---|---|---|---|
| 001073-E |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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Inclusion Criteria for prospective biospecimen collection:
To be eligible to participate in this study, an individual must meet all the following criteria:
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:
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The general community sample will be from Durham, Raleigh, Chapel Hill and other nearby cities close to the NIEHS Clinical Research Unit (CRU).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Lawrence S Kirschner, M.D. | National Institute of Environmental Health Sciences (NIEHS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIEHS Clinical Research Unit (CRU) | Recruiting | Research Triangle Park | North Carolina | 27709 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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Most of the participant data will be utilized by investigators in an aggregate way to validate or invalidate their research.
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