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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00756769
Other study ID # MUSC HR10852
Secondary ID P60AR049459
Status Recruiting
Phase
First received
Last updated
Start date April 2003
Est. completion date June 2027

Study information

Verified date November 2023
Source Medical University of South Carolina
Contact Diane L. Kamen, MD, MSCR
Phone 843-792-4825
Email kamend@musc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. African Americans are at a disproportionately higher risk of developing SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with European Americans. 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 from the Sea Islands of South Carolina and Georgia are unique in their genetic homogeneity with minimal non-African genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of SLE.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date June 2027
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.100 — View Citation

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