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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01087307
First received: March 13, 2010
Last updated: August 19, 2014
Last verified: July 2014

March 13, 2010
August 19, 2014
February 2010
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To generate a pool of biological or environmental samples with which to develop and test specific laboratory assays. [ Time Frame: Two-three years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01087307 on ClinicalTrials.gov Archive Site
Characterize vascular age related-other [ Time Frame: Two-three years ] [ Designated as safety issue: No ]
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Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing
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.

We propose a 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.

Observational
Time Perspective: Prospective
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Biospecimen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
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  • ELIGIBILITY CRITERIA:

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

Both
18 Years and older
Yes
Contact: Lisa B Murphy (919) 541-9839 murphylb@mail.nih.gov
Contact: Stavros Garantziotis, M.D. Not Listed garantziotis@mail.nih.gov
United States
 
NCT01087307
100063, 10-E-0063
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National Institute of Environmental Health Sciences (NIEHS)
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Principal Investigator: Stavros Garantziotis, M.D. National Institute of Environmental Health Sciences (NIEHS)
National Institutes of Health Clinical Center (CC)
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP