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Systemic Lupus Erythematosus in Gullah Health (SLEIGH)
This study is currently recruiting participants.
Verified by Medical University of South Carolina, September 2008
First Received: September 18, 2008   No Changes Posted
Sponsors and Collaborators: Medical University of South Carolina
National Institutes of Health (NIH)
Information provided by: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00756769
  Purpose

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.


Condition
Systemic Lupus Erythematosus

MedlinePlus related topics: Lupus
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Systemic Lupus Erythematosus in Gullah Health

Further study details as provided by Medical University of South Carolina:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Estimated Enrollment: 750
Study Start Date: April 2003
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with SLE
2
Related unaffected controls
3
Unrelated unaffected controls

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Sea Island Community

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756769

Contacts
Contact: Tia Parker, CCRC 843-792-8997 parkerti@musc.edu

Locations
United States, Georgia
Medical College of Georgia Not yet recruiting
Augusta, Georgia, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Diane L. Kamen, MD, MSCR Medical University of South Carolina
  More Information

Publications:
Responsible Party: Medical University of South Carolina ( Diane Kamen, MD, MSCR )
Study ID Numbers: MUSC HR10852, NIH P60 AR049459 ProjC
Study First Received: September 18, 2008
Last Updated: September 18, 2008
ClinicalTrials.gov Identifier: NCT00756769     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Autoimmune Diseases
Lupus Erythematosus, Systemic
Lupus
Connective Tissue Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009