Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Sample Collection for Quality Control of Biologic and Environmental Specimens and Assay Development and Testing
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2007
Sponsored by: National Institute of Environmental Health Sciences (NIEHS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00340197
  Purpose

This study will collect blood and urine samples, household dust samples and saliva samples to be used for developing or evaluating laboratory tests and quality control measures for collecting, handling, storing and testing specimens for the Sister Study, a national study of environmental and genetic risk factors for breast cancer. The samples will help investigators evaluate day-to-day variability in biological and environmental measures, differences between women, the ability of new tests to measure agents of interest, and the levels of agents or biological measures of interest in women in the study age range. This in turn will help scientists improve the quality of research on the role of environmental, dietary and genetic factors in disease.

Adult women between 35 and 74 years of age who are not pregnant and have not had breast cancer may be eligible for this study. Up to 300 women will participate.

  • Blood: Two thirds of the study participants have a single blood sample drawn of about 45 ml (3 tablespoons). One third of the participants have the same size sample drawn on four separate occasions within 12 to 18 months.
  • Urine: Two thirds of the study participants provide a single urine sample. One third of the participants provide a sample on four separate occasions within a 12- to 18-month period.
  • Dust: The participants who provide four blood and urine samples also provide four dust samples from their home, collected on four separate occasions, using alcohol dust wipes provided by the study.
  • Questionnaire: All participants complete a short questionnaire about medications and other exposures they have had in the 24 hours before each blood sample is drawn.

Condition
Quality Control

MedlinePlus related topics: Urine and Urination
U.S. FDA Resources
Study Type: Observational
Official Title: Anonymous Sample Collection for Quality Control of Biological and Environmental Specimens and Assay Development and Testing

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: February 2006
Detailed Description:

We propose a generic protocol for use in obtaining blood, urine, saliva and dust 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 epidemiologic studies and for quality control purposes. In epidemiologic studies involving the storage and analysis of laboratory specimens, it is essential to evaluate the performance of available assays in the target population 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 target 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 target 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 DNA damage and for creation of cell lines. Assays will be performed on lymphocytes prior to freezing and the remaining sample will be cryopreserved to facilitate validation of studies involving frozen lymphocytes and/or immortalized cells. Samples to be collected will include blood and/or urine and/or household dust and/or saliva samples. Although this protocol may be used to evaluate assays for other studies, the primary purpose for this proposal is to provide quality control samples for the Sister Study. Since it is important to collect samples from the target population, this protocol covers collection of samples from non-pregnant women age 35-74 years who have not been diagnosed with breast cancer. The samples will be collected and stored using protocols developed for the Sister Study. This protocol covers two types of collection from non-pregnant adult women. Up to 200 volunteer women will be asked to provide a one-time collection of one blood sample (up to 45 ml) and one urine sample. A subset may be asked to provide a dust sample and/or saliva sample for assay evaluation or develoment purposes. A second group of up to 100 non-pregnant volunteer women will be asked to provide blood (45 ml), urine, household dust, and possible saliva- on as many as seven occasions over a period of approximately one year.

  Eligibility

Ages Eligible for Study:   35 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

All subjects must be 35-74 years of age.

EXCLUSION CRITERIA:

Men, pregnant women and women with a personal history of breast cancer will be excluded.

No children, fetuses, cognitively impaired persons, or prisoners will be enrolled.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340197

Contacts
Contact: Dale Sandler, Ph.D. (919) 541-4668 sandler@niehs.nih.gov

Locations
United States, North Carolina
NIEHS, Research Triangle Park Recruiting
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
  More Information

Study ID Numbers: 999906098, 06-E-N098
Study First Received: June 19, 2006
Last Updated: October 17, 2008
ClinicalTrials.gov Identifier: NCT00340197  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Blood
Urine
Dust
Validation
Laboratory
Sample Collection
Quality Control

ClinicalTrials.gov processed this record on January 16, 2009