Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing

NCT ID: NCT01087307

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-02

Brief Summary

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Background:

\- Researchers are interested in developing a registry protocol to obtain biologic and environmental samples anonymously from adult volunteers for use in laboratory tests and studies. The samples will be used to determine if new tests are sufficiently valid and precise to be used in research studies and for quality control purposes.

Objectives:

\- To provide a registry of samples for test development, validation, analysis, and quality control at the National Institute of Environmental Health Sciences.

Eligibility:

\- Male and nonpregnant female volunteers at least 18 years of age.

Design:

* Samples to be collected will include blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, or sperm.
* Specimens may be collected during a one-time sample collection, or participants may be asked to provide specimens on several occasions over a specified period, not to exceed 1 year.
* Eligible participants will be asked to come to the clinical research unit to have their blood drawn and any noninvasive samples retrieved. Prior to blood draw, researchers will administer a brief past 24-hour questionnaire for research purposes. Specimens will be collected using standard clinical protocols.
* Participants will receive monetary compensation for providing samples for this protocol.

Detailed Description

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We propose a sample collection registry protocol for use in obtaining biologic and environmental samples anonymously from adult volunteers for use in laboratory assay evaluation. The samples will be used to determine if new tests are sufficiently valid and precise to be used in research studies and for quality control purposes. In studies involving the storage and analysis of laboratory specimens, it is essential to evaluate the performance of available assays and to actively assess the impact of storage and handling on the quality of samples and laboratory analyses. Specifically, it is essential to 1) demonstrate that an assay is sufficiently reproducible and stable over time such that differences in levels among individuals in the population can be detected; 2) evaluate assay reliability by sending blinded anonymous samples along with study samples to testing labs for quality control purposes; 3) test proposed laboratories or methods by using replicate samples from the population in order to choose the laboratory or method with the greater precision, and; 4) assess how sample collection, handling, and storage procedures affect measured levels of specific analytes to allow for informed decisions about whether to proceed with a specific analysis. Under this protocol, assays could include evaluation of immunologic parameters, genes and gene products, peptides, proteins, hormones, lipids, viability of cells, evaporation and dilution effects, chemical toxins and their metabolites, micronutrients, metals and more. For some samples, lymphocytes will be extracted for use in studies of lymphocytes and/or immortalized cells. Samples to be collected will include blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, sperm samples, skin cells, and/or sputum. In addition, a pulmonary function test (PFT) may be conducted to collect lung function information. Since it is important to collect samples from the general population, this protocol covers collection of samples from non-pregnant adults (male and female, age 18+). Specimens may be collected during a one-time sample collection, or participants may be asked to provide specimens on several occasions over a specified period, not to exceed one year.

Conditions

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Exposure

Keywords

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Serum Urine Collection Saliva Natural History

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Healthy Adult Volunteer

Healthy adult volunteer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ELIGIBILITY CRITERIA:

All participants must be non-pregnant and 18 years of age or older. No children, cognitively impaired persons, or prisoners will be enrolled.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stavros Garantziotis, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Environmental Health Sciences (NIEHS)

Locations

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NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, United States

Site Status

Countries

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United States

References

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Whitehead GS, Hussain S, Fannin R, Trempus CS, Innes CL, Schurman SH, Cook DN, Garantziotis S. TLR5 Activation Exacerbates Airway Inflammation in Asthma. Lung. 2020 Apr;198(2):289-298. doi: 10.1007/s00408-020-00337-2. Epub 2020 Feb 14.

Reference Type DERIVED
PMID: 32060608 (View on PubMed)

Hussain S, Johnson CG, Sciurba J, Meng X, Stober VP, Liu C, Cyphert-Daly JM, Bulek K, Qian W, Solis A, Sakamachi Y, Trempus CS, Aloor JJ, Gowdy KM, Foster WM, Hollingsworth JW, Tighe RM, Li X, Fessler MB, Garantziotis S. TLR5 participates in the TLR4 receptor complex and promotes MyD88-dependent signaling in environmental lung injury. Elife. 2020 Jan 28;9:e50458. doi: 10.7554/eLife.50458.

Reference Type DERIVED
PMID: 31989925 (View on PubMed)

Saini N, Roberts SA, Klimczak LJ, Chan K, Grimm SA, Dai S, Fargo DC, Boyer JC, Kaufmann WK, Taylor JA, Lee E, Cortes-Ciriano I, Park PJ, Schurman SH, Malc EP, Mieczkowski PA, Gordenin DA. The Impact of Environmental and Endogenous Damage on Somatic Mutation Load in Human Skin Fibroblasts. PLoS Genet. 2016 Oct 27;12(10):e1006385. doi: 10.1371/journal.pgen.1006385. eCollection 2016 Oct.

Reference Type DERIVED
PMID: 27788131 (View on PubMed)

Related Links

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Other Identifiers

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10-E-0063

Identifier Type: -

Identifier Source: secondary_id

100063

Identifier Type: -

Identifier Source: org_study_id