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A Normal Donor Sample Collection Study in Healthy Adults

NCT ID: NCT01318863

Last Updated: 2011-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Brief Summary

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More than one site will participate in the collection of blood and urine samples from healthy adult subjects. These samples will be used for future testing to serve as aged-matched normal controls and to establish normal reference ranges in the development of new invitro diagnostic devices.

Detailed Description

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Conditions

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Healthy Normal Volunteers

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy adults (age ≥ 21 years)
* Provide written informed consent for study participation

Exclusion Criteria

* Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
* Any known or suspected significant chronic medical conditions (such as diabetes, coronary artery disease, renal insufficiency, hypertension, hypercholesterolemia, chronic inflammatory diseases \[e.g., rheumatoid arthritis\], cancer, etc);
* Trauma-related surgery within the last 6 months;
* Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
* Received any blood product transfusion within the previous 2 months;
* Pregnant women or children;
* Prisoners or institutionalized individuals;
* Already provided blood or urine samples for this study.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astute Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Apex Research Institute

Santa Ana, California, United States

Site Status

Clinical Research Consortium

Las Vegas, Nevada, United States

Site Status

Rochester Clinical Research, Inc.

Rochester, New York, United States

Site Status

Gray, Tennessee, United States

Site Status

Memphis, Tennessee, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AST-015

Identifier Type: -

Identifier Source: org_study_id