Systemic Lupus Erythematosus in Gullah Health (SLEIGH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00756769
First received: September 18, 2008
Last updated: August 11, 2011
Last verified: August 2011

September 18, 2008
August 11, 2011
April 2003
April 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00756769 on ClinicalTrials.gov Archive Site
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Systemic Lupus Erythematosus in Gullah Health
Systemic Lupus Erythematosus in Gullah Health

Systemic lupus erythematosus (SLE) is a severe, disabling systemic autoimmune disease characterized by the production of autoantibodies. The clinical symptoms and immunologic manifestations of SLE are diverse. African-Americans have a 3 fold increased incidence of SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with Caucasians. Our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of SLE. The African-American Gullah population lives on the Sea Islands of South Carolina and Georgia. They are unique in their genetic homogeneity with minimal Caucasian admixture, making them an ideal cohort to address questions of environmental and genetic influence on development and progression of SLE.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Sea Island Community

Systemic Lupus Erythematosus
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  • 1
    Patients with SLE
  • 2
    Related unaffected controls
  • 3
    Unrelated unaffected controls
Kamen DL, Barron M, Parker TM, Shaftman SR, Bruner GR, Aberle T, James JA, Scofield RH, Harley JB, Gilkeson GS. Autoantibody prevalence and lupus characteristics in a unique African American population. Arthritis Rheum. 2008 May;58(5):1237-47.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 2 years and above;
  • Self-identified as African-American "Gullah" from the Sea Island region of South Carolina;
  • Have had at least 4 of the 11 diagnostic criteria for SLE as designated by the American College of Rheumatology (ACR), be a relative of a known SLE patient, or be an unrelated healthy Gullah control;
  • Ability to speak and understand English;
  • Ability and willingness to give informed consent

Exclusion Criteria:

  • Race defined by participant as other than Black or African-American;
  • Being a prisoner, mentally ill patient, or institutionalized individual;
  • Unwilling or unable to give informed consent
Both
2 Years and older
Yes
Contact: Stephanie Slan 843-792-8997 slans@musc.edu
United States
 
NCT00756769
MUSC HR10852, P60AR049459
No
Diane Kamen, MD, MSCR, Medical University of South Carolina
Medical University of South Carolina
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Diane L. Kamen, MD, MSCR Medical University of South Carolina
Medical University of South Carolina
August 2011

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