Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01087307 |
| Other study ID # |
100063 |
| Secondary ID |
10-E-0063 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2, 2010 |
Study information
| Verified date |
February 23, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
