Clinical trial NCT01266915: Cutaneous Lupus Registry
Official title: Molecular Studies on Cutaneous Lupus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Erythematosus
Keywords: SCLE
CLE
DLE
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with Lupus Erythematosus

Brief summary: Approximately 1.4 million individuals in the United States have systemic lupus erythematosus, and about 85% of these individuals develop skin lesions at some point of their disease. Cutaneous lupus erythematosus represents the skin manifestations of systemic lupus erythematosus, and can appear in people with or without systemic lupus. It is a mentally, physically, and emotionally debilitating disease that affects both the quality of life and social well-being of those affected.

The cause of cutaneous lupus is not completely understood, but likely includes multiple factors from our genes and the environment. Multiple genetic studies with small numbers of cutaneous lupus patients have been performed to determine which genes are associated with cutaneous lupus. This study aims to accumulate even larger numbers of patients to confidently identify genes and the proteins they encode that could contribute greatly to the formation of cutaneous lupus. The discovery of these genes and proteins would help not only uncover how cutaneous lupus forms, but also improve our abilities to diagnose this disease and predict its course, and stimulate new drug development.

Detailed description: The purpose of this study is to create a national registry of patients with cutaneous lupus patients in order to address many unknown questions about this disease. Specifically, we are interested in better understanding the causes of cutaneous lupus and improving our methods of diagnosis, prognosis, and management of this disease. We plan to use information from all patient sources, including medical histories, clinical information, laboratory data, and blood and skin samples in order to answer these questions.

Each study patient will be asked to complete a series of questionnaires, which, for example, will ask about cutaneous and/or systemic lupus history, past medical history, family history, quality of life, and sun protective habits. Patients will be also asked to donate blood and skin samples and undergo digital photography of affected areas. No treatments will be administered as part of this study, but all participants will be notified of clinical trials being conducted at UT Southwestern. This study is for the purpose of data collection only. Patients will be asked to be followed on an annual basis for five years.

Eligibility 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

Primary outcomes:
measure: Genes
timeFrame: 5 years
measure: Proteins (ie. signaling proteins, autoantibodies)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Dallas
state: Texas
Study officials:
References: