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

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.

Study Overview

• Status: Completed
• Conditions: Exposure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5326

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • NIEHS, Research Triangle Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Adult Volunteer; Healthy adult volunteer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The endpoint is to create a biobank of samples which can be used for development and optimization of assays.	The objective of each collection is to generate a small pool of biological or environmental samples with which to develop and test 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.	24 hours

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2010

Study Registration Dates

• First Submitted: March 13, 2010
• First Submitted That Met QC Criteria: March 13, 2010
• First Posted (Estimated): March 16, 2010

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: February 23, 2024

More Information

Terms related to this study

• Keywords: Natural History; Serum; Saliva; Urine Collection
• Other Study ID Numbers: 100063; 10-E-0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: .There is no current plan to make IDP available to others.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No