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
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic Lupus Erythematosus in Gullah Health

Resource links provided by NLM:


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

Estimated Enrollment: 750
Study Start Date: April 2003
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
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: NCT00756769

Contacts
Contact: Stephanie Slan 843-792-8997 slans@musc.edu

Locations
United States, Georgia
Medical College of Georgia Recruiting
Augusta, Georgia, United States, 30912
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: Diane Kamen, MD, MSCR, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00756769     History of Changes
Other Study ID Numbers: MUSC HR10852, P60AR049459
Study First Received: September 18, 2008
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014