Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01266915 |
| Other study ID # |
STU 112008-008 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2009 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
Benjamin Chong, MD, MSCS |
| Phone |
214-648-3427 |
| Email |
skinlupus.registry[@]utsouthwestern.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
