NIEHS Repository of Stored Biological Samples for Future Use

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Environmental Health Sciences (NIEHS)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: healthy controls

Trial outcomes

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.

Time frame
On-going

Secondary outcomes

Other outcomes

Sponsors and contacts

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