Collection of Biological and Environmental Samples and Clinical Data From Anonymous Adult Men and Women for Quality Control and Methods Development and Evaluation (ASCA)
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/11/2018 |
| Start Date: | October 19, 2016 |
| End Date: | June 1, 2026 |
| Contact: | Christie Barker-Cummings |
| Email: | cbarkercummings@s-3.com |
| Phone: | (919) 287-4354 |
Background:
Scientists want to improve new studies on how the environment, diet, and genetic factors
affect human health. To do this, they need biological samples and clinical data. They want to
find better ways to collect, handle, store, and test these samples and data. This could make
them more useful for research.
Objective:
To collect anonymous samples and clinical data from people. To find better ways to collect,
handle, store, and test them to support health research.
Eligibility:
Healthy people ages 18 and older
Design:
Participants will complete a screening form by phone or in person. The form could include
questions about age, race, ethnicity, menopause status, or pregnancy.
Participants will donate a specific amount of a sample. This could be blood, breast milk,
cerumen, ear wax, exhaled breath, hair, mucosal or skin cells, nail clippings, saliva, semen,
stool, or urine.
Participants may provide an environmental sample such as dust, water, soil, air, or plant
life.
Participants may get kits to collect their samples. They may also donate them at a clinic
visit.
Visit will take about 30 minutes. They may include:
Sample collection
Questions about diet, smoking, alcohol use, medication, menstrual cycle, and health
Measurement of body composition, naturally occurring radioactivity, or Doppler blood flow
Moderate exercise
Flexibility, muscle strength, or sensory testing
Participants may be asked to participate several times during the study.
Scientists want to improve new studies on how the environment, diet, and genetic factors
affect human health. To do this, they need biological samples and clinical data. They want to
find better ways to collect, handle, store, and test these samples and data. This could make
them more useful for research.
Objective:
To collect anonymous samples and clinical data from people. To find better ways to collect,
handle, store, and test them to support health research.
Eligibility:
Healthy people ages 18 and older
Design:
Participants will complete a screening form by phone or in person. The form could include
questions about age, race, ethnicity, menopause status, or pregnancy.
Participants will donate a specific amount of a sample. This could be blood, breast milk,
cerumen, ear wax, exhaled breath, hair, mucosal or skin cells, nail clippings, saliva, semen,
stool, or urine.
Participants may provide an environmental sample such as dust, water, soil, air, or plant
life.
Participants may get kits to collect their samples. They may also donate them at a clinic
visit.
Visit will take about 30 minutes. They may include:
Sample collection
Questions about diet, smoking, alcohol use, medication, menstrual cycle, and health
Measurement of body composition, naturally occurring radioactivity, or Doppler blood flow
Moderate exercise
Flexibility, muscle strength, or sensory testing
Participants may be asked to participate several times during the study.
Objective:
We propose a common protocol for use in non-invasive (i.e., minimal risk, not involving
general anesthesia or sedation) collection of biological and environmental samples and
clinical data from anonymous adult volunteers for methods testing and protocol development,
quality control, methods development and evaluation. Individual collections conducted under
this protocol will submit actual advertisements, forms and names of persons obtaining consent
for IRB expedited review.
Study Population:
This protocol covers recruitment of healthy non-pregnant adults (men and women age 18+)
and/or pregnant adult women (age 18+).
Design:
All clinical data and sample collection will be performed by clinical and research
professionals as appropriate. Biological samples that may be collected include blood or
plasma, breast milk, cerumen, exhaled breath, hair, mucosal and skin cells, nail clippings,
saliva, semen, stool and urine. In some cases, lymphocytes will be isolated from blood and
immortalized. Clinical data may be collected through non-invasive procedures routinely
employed in research and clinical practice, and using medical devices approved for marketing
(excluding procedures involving x-rays or microwaves). Clinical data collection may include
anthropomorphic measurement, body composition assessment, detection of naturally occurring
radioactivity, Doppler blood flow, exhaled breath, flexibility testing, moderate exercise,
muscular strength testing, physical sensors, and sensory acuity testing where appropriate
given the age, weight and health of the individual. Environmental samples may include dust,
water, soil, air, vegetation, and other environmental samples that may be collected without
damage to property. Compensation for clinical data and sample donation will depend on the
time and effort involved in donation. Samples and clinical data may be collected during a
one-time collection, or participants may be asked to provide samples and clinical data on
several occasions over a specified period.
Outcome Measures:
The samples and clinical and response data will be used to determine if proposed research
designs are feasible and if methods are sufficiently valid and precise to be used in
epidemiologic studies. They will also be used for quality control purposes in study sample
analysis projects. In epidemiologic studies involving the collection, storage and analysis of
laboratory samples, it is essential to evaluate the performance of available assays and to
assess the impact of storage and handling on the quality of samples
and laboratory analyses. It is also necessary to determine levels of specific biomarkers in
the population to aid in study design as well as willingness of specific population groups to
provide necessary samples and data. It is essential 1) to demonstrate that a method is
sufficiently reproducible and stable over time such that differences in measurements among
individuals in the population can be detected; 2) to evaluate measurement reliability by
sending blinded control samples along with study samples to testing laboratories
for quality control purposes; 3) to test proposed laboratories or methods by using replicate
samples in order to choose the laboratory or method with the greater precision; and 4) to
assess how collection, handling, and storage procedures affect measured levels of specific
analytes to allow informed decisions about whether to proceed with a specific analysis; 5) to
determine levels and distributions of proposed biomarkers to assess study feasibility and
determine appropriate study sample size; and 6) evaluate approaches to recruiting
participants for proposed studies with specific sample collection requirements. Under this
protocol, methods may include analyses of genes and gene products, peptides, proteins,
lipids, immunologic parameters, hormones, viability of cells, evaporation and dilution
effects, chemical toxicants and their metabolites, metals, micronutrients and other analytes.
We propose a common protocol for use in non-invasive (i.e., minimal risk, not involving
general anesthesia or sedation) collection of biological and environmental samples and
clinical data from anonymous adult volunteers for methods testing and protocol development,
quality control, methods development and evaluation. Individual collections conducted under
this protocol will submit actual advertisements, forms and names of persons obtaining consent
for IRB expedited review.
Study Population:
This protocol covers recruitment of healthy non-pregnant adults (men and women age 18+)
and/or pregnant adult women (age 18+).
Design:
All clinical data and sample collection will be performed by clinical and research
professionals as appropriate. Biological samples that may be collected include blood or
plasma, breast milk, cerumen, exhaled breath, hair, mucosal and skin cells, nail clippings,
saliva, semen, stool and urine. In some cases, lymphocytes will be isolated from blood and
immortalized. Clinical data may be collected through non-invasive procedures routinely
employed in research and clinical practice, and using medical devices approved for marketing
(excluding procedures involving x-rays or microwaves). Clinical data collection may include
anthropomorphic measurement, body composition assessment, detection of naturally occurring
radioactivity, Doppler blood flow, exhaled breath, flexibility testing, moderate exercise,
muscular strength testing, physical sensors, and sensory acuity testing where appropriate
given the age, weight and health of the individual. Environmental samples may include dust,
water, soil, air, vegetation, and other environmental samples that may be collected without
damage to property. Compensation for clinical data and sample donation will depend on the
time and effort involved in donation. Samples and clinical data may be collected during a
one-time collection, or participants may be asked to provide samples and clinical data on
several occasions over a specified period.
Outcome Measures:
The samples and clinical and response data will be used to determine if proposed research
designs are feasible and if methods are sufficiently valid and precise to be used in
epidemiologic studies. They will also be used for quality control purposes in study sample
analysis projects. In epidemiologic studies involving the collection, storage and analysis of
laboratory samples, it is essential to evaluate the performance of available assays and to
assess the impact of storage and handling on the quality of samples
and laboratory analyses. It is also necessary to determine levels of specific biomarkers in
the population to aid in study design as well as willingness of specific population groups to
provide necessary samples and data. It is essential 1) to demonstrate that a method is
sufficiently reproducible and stable over time such that differences in measurements among
individuals in the population can be detected; 2) to evaluate measurement reliability by
sending blinded control samples along with study samples to testing laboratories
for quality control purposes; 3) to test proposed laboratories or methods by using replicate
samples in order to choose the laboratory or method with the greater precision; and 4) to
assess how collection, handling, and storage procedures affect measured levels of specific
analytes to allow informed decisions about whether to proceed with a specific analysis; 5) to
determine levels and distributions of proposed biomarkers to assess study feasibility and
determine appropriate study sample size; and 6) evaluate approaches to recruiting
participants for proposed studies with specific sample collection requirements. Under this
protocol, methods may include analyses of genes and gene products, peptides, proteins,
lipids, immunologic parameters, hormones, viability of cells, evaporation and dilution
effects, chemical toxicants and their metabolites, metals, micronutrients and other analytes.
- INCLUSION CRITERIA:
All subjects must be 18 years of age or older and able to provide informed consent. All
subjects must be healthy as defined by the American Red Cross - "'Healthy' means that you
feel well and can perform normal activities. If you have a chronic condition such as
diabetes or high blood pressure, healthy also means that you are being treated and the
condition is under control."
EXCLUSION CRITERIA:
No children, fetuses, cognitively impaired persons, or prisoners will be enrolled.
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