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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
  Purpose

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
Antiphospholipid Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Biospecimen Retention:   Samples With DNA

Serum, plasma, genomic DNA


Enrollment: 860
Study Start Date: April 2000
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Specialty and subspecialty clinics

Criteria

Inclusion Criteria:

  • Antiphospholipid antibodies with or without associated clinical manifestations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076713

Locations
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
  More Information

Additional Information:
Publications:
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
Study First Received: February 2, 2004
Last Updated: February 11, 2013
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Antiphospholipid

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

ClinicalTrials.gov processed this record on November 25, 2014