Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lupus Genetics Studies (LFRR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00071175
First received: October 14, 2003
Last updated: November 14, 2008
Last verified: November 2008

October 14, 2003
November 14, 2008
October 1995
September 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00071175 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lupus Genetics Studies
Lupus Genetic Studies; Lupus Family Registry & Repository

The Lupus Genetics Studies and Lupus Family Registry & Repository are working to find the genes that reveal the causes of systemic lupus erythematosus (SLE, or lupus). The study is enrolling families of all ethnic backgrounds from the United States, Canada, Puerto Rico, and the Virgin Islands that have one or more living members diagnosed with SLE.

SLE is an often crippling and potentially fatal autoimmune disease that is nine times more prevalent in women than in men, and four times more likely to affect African American females than Caucasian females. It is suspected that a genetic predisposition along with environmental factors contribute to the clinical manifestation of SLE. The Lupus Genetics Studies consist of several familial SLE studies, including the Lupus Family Registry & Repository (LFRR, formerly known as the Lupus Multiplex Registry & Repository, or LMRR). The Lupus Studies enroll families of all ethnicities with one or more members diagnosed with systemic lupus to determine what genes contribute to the development of the disease.

Additionally, the Lupus Family Registry & Repository is the largest repository of its kind in North America. In addition to the research done on site, the Repository serves as a national resource for scientists interested in conducting research on SLE and families either simplex or multiplex for lupus. Data, serum samples, and DNA samples are available to researchers. By collecting families in which two or more living individuals have been diagnosed with SLE, the study is utilizing the genetic link between the affected family members to discover disease-associated genes.

Records will be requested from the patients' treating physicians to document various lupus symptoms and related problems. One-time blood samples will be collected from the patients as well as from certain family members and an unrelated volunteer. There is no cost to participate and the study pays for sample draws and shipping.

Observational
Observational Model: Family-Based
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

DNA, sera, plasma, cell lines

Non-Probability Sample

Patients diagnosed with SLE Families with living members diagnosed with SLE

Systemic Lupus Erythematosus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18000
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Families in which one or more living members have been diagnosed with systemic lupus erythematosus
Both
Not Provided
Yes
Contact: Recruiters 1-888-655-8787 lupus-recruiters@lupus.omrf.org
United States
 
NCT00071175
NIAMS-103, AI24717, AR42460, AR049084, AR52253, AR62277
No
John B. Harley, MD, PhD; Principal Investigator, Oklahoma Medical Research Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: John B. Harley, MD, PhD Member & Program Head, Arthritis and Immunology Research Program; Oklahoma Medical Research Foundation
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP