Molecular Studies on Cutaneous Lupus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proteins (ie. signaling proteins, autoantibodies)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proteins (ie. signaling proteins, autoantibodies)
时间窗: 5 years
Genes
时间窗: 5 years
次要结局
未报告次要终点
研究者
Ben Chong
Professor
University of Texas Southwestern Medical Center