A Normal Donor Sample Collection Study in Healthy Adults

Astute Medical

Status: Completed

Conditions: Healthy Normal Volunteers

Study type: Observational

Funder types: Industry

Identifiers

NCT01318863

AST-015

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.