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Antiphospholipid Syndrome Collaborative Registry (APSCORE)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Robert Roubey, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00076713
First received: February 2, 2004
Last updated: February 11, 2013
Last verified: February 2013

February 2, 2004
February 11, 2013
April 2000
April 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00076713 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Antiphospholipid Syndrome Collaborative Registry (APSCORE)
Antiphospholipid Syndrome Collaborative Registry (APSCORE)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, plasma, genomic DNA

Non-Probability Sample

Specialty and subspecialty clinics

Antiphospholipid Syndrome
Not Provided
Not Provided
Roubey RA. New approaches to prevention of thrombosis in the antiphospholipid syndrome: hopes, trials, and tribulations. Arthritis Rheum. 2003 Nov;48(11):3004-8. Review. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
860
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Antiphospholipid antibodies with or without associated clinical manifestations
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076713
NIAMS-099, N01AR002248-000
No
Robert Roubey, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Center on Minority Health and Health Disparities (NCMHD)
Not Provided
University of North Carolina, Chapel Hill
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP