Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing
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|ClinicalTrials.gov Identifier: NCT01087307|
Recruitment Status : Recruiting
First Posted : March 16, 2010
Last Update Posted : February 11, 2021
|First Submitted Date||March 13, 2010|
|First Posted Date||March 16, 2010|
|Last Update Posted Date||February 11, 2021|
|Actual Study Start Date||February 22, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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|
|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|
- 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.
- To provide a registry of samples for test development, validation, analysis, and quality control at the National Institute of Environmental Health Sciences.
- Male and nonpregnant female volunteers at least 18 years of age.
|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 Design||Observational Model: Other
Time Perspective: Other
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Healthy Volunteers|
Biologic and environmental samples anonymously obtained from adult volunteers for use in laboratory assay evaluation
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
All participants must be non-pregnant and 18 years of age or older. No children, cognitively impaired persons, or prisoners will be enrolled.
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100063
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )|
|Study Sponsor||National Institute of Environmental Health Sciences (NIEHS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2, 2020|