Registry for patients with cutaneous lupus
Molecular Studies on Cutaneous Lupus
This study is creating a national registry for people with cutaneous lupus to collect information that will help understand the condition better and improve how it's diagnosed and managed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT01266915 on ClinicalTrials.gov |
What this trial studies
This study aims to create a national registry for individuals diagnosed with cutaneous lupus erythematosus and systemic lupus erythematosus. By collecting comprehensive data, including medical histories, clinical information, and biological samples, the study seeks to better understand the causes and improve the diagnosis and management of cutaneous lupus. Participants will complete questionnaires and provide blood and skin samples, with follow-ups conducted annually for five years. The study does not involve any treatments but will inform participants about relevant clinical trials.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with cutaneous lupus erythematosus or systemic lupus erythematosus who can provide informed consent.
Not a fit: Patients under 18 years of age or those whose cutaneous lupus resolves with medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cutaneous lupus, enhancing the quality of life for patients.
How similar studies have performed: While there have been smaller genetic studies on cutaneous lupus, this registry approach is novel and aims to gather a larger patient population for more comprehensive insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings * Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish) * Ability to give written informed consent Exclusion Criteria: * Less than 18 years of age, since the characteristics of the disease in these subjects could be very different * Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different * Medical conditions who do not warrant a skin biopsy * Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Benjamin Chong, MD, MSCS
- Email: skinlupus.registry@utsouthwestern.edu
- Phone: 214-648-3427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.