Systemic Lupus Erythematosus in Gullah Health

NCT ID: NCT00756769

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with SLE

No interventions assigned to this group

2

Related unaffected controls

No interventions assigned to this group

3

Unrelated unaffected controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diane L. Kamen, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Diane L. Kamen, MD, MSCR

Role: CONTACT

843-792-4825

References

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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: 10.1002/art.23416.

Reference Type BACKGROUND
PMID: 18438839 (View on PubMed)

Other Identifiers

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P60AR049459

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MUSC HR10852

Identifier Type: -

Identifier Source: org_study_id

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