Collection of Biological and Environmental Samples and Clinical Data From Anonymous Adult Men and Women for Quality Control and Methods Development and Evaluation (ASCA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- The samples and clinical data will be used to ascertain whether data and sample collection, processing techniques, and testing methods are sufficiently valid and precise to be used in specific epidemiologic studies.
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The samples and clinical data will be used to ascertain whether data and sample collection, processing techniques, and testing methods are sufficiently valid and precise to be used in specific epidemiologic studies.
Time Frame: will vary by sub study effort
Evaluations of the performance of available assays; assessments of theimpact of storage and handling on the quality of samples and laboratory analyses; determinations of the 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
Secondary Outcomes
No secondary outcomes reported