Systemic Lupus Erythematosus in Gullah Health (SLEIGH)

November 19, 2023 updated by: Diane Kamen, Medical University of South Carolina
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Diane L. Kamen, MD, MSCR
  • Phone Number: 843-792-4825
  • Email: kamend@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Sea Island Community

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with SLE
2
Related unaffected controls
3
Unrelated unaffected controls

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

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

Investigators

  • Principal Investigator: Diane L. Kamen, MD, MSCR, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimated)

September 22, 2008

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSC HR10852
  • P60AR049459 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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