Sample Collection Registry for Quality Control of Biological and Environmental Specimens and Assay Development and Testing
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/20/2018 |
| Start Date: | February 16, 2010 |
| Contact: | Lisa B Barber, MEd |
| Email: | lisa.barber@nih.gov |
| Phone: | (984) 287-4410 |
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.
- 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.
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.
- 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.
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