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Antiphospholipid Syndrome Collaborative Registry (APSCORE) (APSCORE)

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ClinicalTrials.gov Identifier: NCT00076713
Recruitment Status : Completed
First Posted : February 3, 2004
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. Patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. APS may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals.

The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and tissue repository for patients with APS. This registry will collect clinical information and blood samples from people with APS.

Condition or disease
Antiphospholipid Syndrome

Detailed Description:

Registry participants will have a blood sample drawn and will be interviewed about their medical histories. Participants will be asked to return for a follow-up visit after two years. Clinical, demographic, and laboratory data will be collected. Registry resources will be made available to researchers and medical practitioners to support a broad range of research on the causes, diagnosis, mechanisms, and treatment of APS.

The University of North Carolina at Chapel Hill is the coordinating center and an enrollment site for the registry. There are seven other enrollment sites: Ball Memorial Hospital, Muncie, IN; Duke University, Durham, NC; Hospital for Special Surgery, New York, NY; Johns Hopkins University, Baltimore, MD; Morehouse School of Medicine, Atlanta, GA; University of Texas Health Science Center, San Antonio, TX; and University of Utah Health Science Center, Salt Lake City, UT.

Study Design

Study Type : Observational
Actual Enrollment : 860 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antiphospholipid Syndrome Collaborative Registry (APSCORE)
Study Start Date : April 2000
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA
Serum, plasma, genomic DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Specialty and subspecialty clinics

Inclusion Criteria:

  • Antiphospholipid antibodies with or without associated clinical manifestations
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076713

United States, Georgia
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, New York
Hospital for Special Surgery, Weill-Cornell University Medical Center
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Health Science Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Minority Health and Health Disparities (NIMHD)
More Information

Additional Information:
Responsible Party: Robert Roubey, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00076713     History of Changes
Other Study ID Numbers: NIAMS-099
N01AR002248-000 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2004    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Robert Roubey, MD, University of North Carolina, Chapel Hill:

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Pathologic Processes
Autoimmune Diseases
Immune System Diseases