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Systemic Lupus Erythematosus in Gullah Health (SLEIGH)

This study is currently recruiting participants.
Verified August 2016 by Diane Kamen, Medical University of South Carolina
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756769
First Posted: September 22, 2008
Last Update Posted: August 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Diane Kamen, Medical University of South Carolina
  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 Diane Kamen, Medical University of South Carolina:

Estimated Enrollment: 750
Study Start Date: April 2003
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with SLE
2
Related unaffected controls
3
Unrelated unaffected controls

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Diane L. Kamen, MD, MSCR Medical University of South Carolina
  More Information

Publications:
Responsible Party: Diane Kamen, Associate Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00756769     History of Changes
Other Study ID Numbers: MUSC HR10852
P60AR049459 ( U.S. NIH Grant/Contract )
First Submitted: September 18, 2008
First Posted: September 22, 2008
Last Update Posted: August 16, 2016
Last Verified: August 2016

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