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

• ClinicalTrials.gov Identifier: NCT01087307
• Recruitment Status: Completed
• First Posted: March 16, 2010
• Last Update Posted: April 10, 2023
• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Tracking Information

• First Submitted Date: March 13, 2010
• First Posted Date: March 16, 2010
• Last Update Posted Date: April 10, 2023
• Actual Study Start Date: March 2, 2010
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: August 17, 2019)

The endpoint is to create a biobank of samples which can be used for development and optimization of assays. [ Time Frame: 24 hours ]

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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing
• Official Title: Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing

Brief Summary

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: 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
• Study Design: Observational Model: Other; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Healthy Volunteers
• Condition: Exposure
• Intervention: Not Provided

Study Groups/Cohorts

Healthy Adult Volunteer

Healthy adult volunteer

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2022): 5326
• Original Estimated Enrollment (submitted: March 13, 2010): 5000
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01087307
• Other Study ID Numbers: 100063; 10-E-0063
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: .There is no current plan to make IDP available to others.

• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: March 27, 2023