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Cutaneous Lupus Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Ben Chong, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01266915
First received: December 23, 2010
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition
Lupus Erythematosus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Studies on Cutaneous Lupus

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Genes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Proteins (ie. signaling proteins, autoantibodies) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control group
Normal disease free (non lupus) subjects
Diseased Control
Diseased group 1
Those subjects with systemic lupus erythematosus.
Diseased group 2
Subjects diagnosed with cutaneous lupus.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects diagnosed with Lupus Erythematosus

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266915

Contacts
Contact: Andrew Kim 214-638-1859 skinlupus.registry@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Andrew Kim    214-633-1859    skinlupus.registry@utsouthwestern.edu   
Contact: Benjamin F Chong, MD    214-643-1837      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Ben Chong, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01266915     History of Changes
Other Study ID Numbers: 112008-008
Study First Received: December 23, 2010
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
SCLE
CLE
DLE

ClinicalTrials.gov processed this record on November 24, 2014