NCT01318863

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

November 7, 2011

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

March 17, 2011

Last Update Submit

November 3, 2011

Conditions

Keywords

aged matched normal control samples

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Adults

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Unknown Facility

Gray, Tennessee, 37615, United States

Location

Unknown Facility

Memphis, Tennessee, 38105, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 21, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2011

Last Updated

November 7, 2011

Record last verified: 2011-09

Locations