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Lupus Genetics Studies (LFRR)

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ClinicalTrials.gov Identifier: NCT00071175
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : September 18, 2017
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation

Tracking Information
First Submitted Date October 14, 2003
First Posted Date October 15, 2003
Last Update Posted Date September 18, 2017
Study Start Date October 1995
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lupus Genetics Studies
Official Title Lupus Genetic Studies; Lupus Family Registry & Repository
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, sera, plasma, cell lines
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with SLE Families with living members diagnosed with SLE
Condition Systemic Lupus Erythematosus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October¬†13,¬†2015)
3460
Original Enrollment Not Provided
Actual Study Completion Date November 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Families in which one or more living members have been diagnosed with systemic lupus erythematosus
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00071175
Other Study ID Numbers NIAMS-103
5P01AR049084-09 ( U.S. NIH Grant/Contract )
AI24717
AR42460
AR049084
AR52253
AR62277
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oklahoma Medical Research Foundation
Study Sponsor Oklahoma Medical Research Foundation
Collaborators
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: John B. Harley, MD, PhD Member & Program Head, Arthritis and Immunology Research Program; Oklahoma Medical Research Foundation
PRS Account Oklahoma Medical Research Foundation
Verification Date September 2017